(199 days)
The eufy Wearable Breast Pump S1 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The eufy Wearable Breast Pump E10 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The eufy Wearable Breast Pump is an electrically powered wearable single breast pump. There are two models, eufy Wearable Breast Pump S1 (T8DO2) and eufy Wearable Breast Pump E10 (T8DO3). S1 consists of a Pump Hub, Diaphragm, Milk Container, Pouring Spout, Heating Pins, Flange, Duckbill Valve and charging pins. E10 consists of Pump Hub, Diaphragm, Milk Container, Pouring Spout, Flange and Duckbill Valve.
The differences between S1 and E10 are as follows:
- E10 has no heating function (S1 has a heating function);
- The charging method is different (S1 for magnetic charging, E10 for Type-C charging).
The eufy Wearable Breast Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1460mAh). The eufy Wearable Breast Pump cannot be operated while it is being charged.
The eufy Wearable Breast Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment. An optional smartphone app may be used with the Breast Pump. The app may be used to control the operation of The Breast Pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Breast Pump.
The eufy Wearable Breast Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.
The eufy Wearable Breast Pump allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 7 vacuum levels, capable of providing suction from -75 to -292.5mmHg, with cycle speeds ranging from 71 to 110 cycles/minute in stimulation mode and 39 to 60 cycles/minute in expression mode.
The provided FDA 510(k) clearance letter and summary for the eufy Wearable Breast Pumps (S1 and E10) do not contain information about a clinical study involving human subjects or AI components that would require acceptance criteria related to accuracy, sensitivity, or specificity.
The document describes non-clinical performance testing for the device, which primarily focuses on:
- Electrical Safety, Electromagnetic Compatibility: Compliance with standards like ANSI AAMI ES60601-1, IEC 60601-1-2, HA60601-1-11, and IEC 62133-2.
- Performance testing: Verification of vacuum suction pressure & cycle speed, backflow protection, battery capacity, operating time/charging time, and use life testing. "Device specifications were met for all tests conducted." This statement indicates internal acceptance criteria were met, but the specific numerical criteria are not detailed in this summary.
- Packaging simulation testing: Compliance with ISTA 3A: 2018.
- Biocompatibility: Compliance with ISO 10993-1, 10993-5, 10993-10, and 10993-23. "The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing." These are the acceptance criteria.
- Software: Evaluation based on FDA guidance documents for device software functions.
- Cybersecurity: Evaluation based on FDA guidance for cybersecurity in medical devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way you've requested (e.g., accuracy, sensitivity, specificity), nor can I answer questions about sample size for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for clinical data, as this information is not present in the provided text.
The provided document indicates that the device has "embedded software" and an "optional smartphone app," but there's no mention of these software components being AI-driven in a way that would necessitate performance metrics like those typically seen for AI/ML devices (e.g., for diagnosis, prediction, or image analysis). The app primarily controls the pump and displays basic information like milk quantity.
Based on the provided text, the device is a powered breast pump, and its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.
To summarize what can be inferred from the provided text regarding acceptance and testing:
Acceptance Criteria and Study for eufy Wearable Breast Pump
The acceptance criteria and study detailed in the provided 510(k) summary are focused on the safety and performance of the electromechanical device as a powered breast pump, rather than on diagnostic or AI-powered functions requiring clinical accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied/Stated) | Reported Device Performance (Implied/Stated) |
|---|---|---|
| Electrical Safety | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, HA60601-1-11. | Device passed safety testing according to specified standards. |
| Battery Safety | Compliance with IEC 62133-2. | Device passed battery testing according to specified standards. |
| Functional Performance | Meet device specifications for: vacuum suction pressure, cycle speed, backflow protection, battery capacity, operating time, charging time, use life. | "Device specifications were met for all tests conducted." (Specific numerical thresholds not provided in this summary). |
| Packaging Integrity | Compliance with ISTA 3A: 2018. | Packaging simulation testing conducted and met the standard. |
| Biocompatibility (Contacting Materials) | Non-cytotoxic, non-irritating, non-sensitizing (per ISO 10993-5, 10993-10, 10993-23). | User-contacting materials "were shown to be non-cytotoxic, non-irritating, and non-sensitizing." |
| Software | Compliance with FDA guidance "Content of Premarket Submissions for Device Software Functions" (Basic Documentation level). | Software was evaluated at the Basic Documentation level. |
| Cybersecurity | Compliance with FDA's Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." | Cybersecurity was evaluated according to the guidance. |
2. Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing on the device itself (e.g., how many units were tested for vacuum, battery life, etc.). The sample sizes for these engineering or lab tests (e.g., number of breast pumps tested) and their provenance (e.g., manufactured in China, tested in specific lab environments) are not detailed in this 510(k) summary. There is no mention of a clinical test set involving human subjects for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information pertains to studies where expert interpretation (e.g., for medical images) forms the ground truth. The acceptance criteria here relate to physical device performance and safety standards, which are evaluated by engineers and lab technicians against predefined specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this device is a breast pump, not an AI-driven diagnostic or interpretative tool for which human readers would interact.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This applies to AI/ML algorithms, not the core function of a breast pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance testing, the "ground truth" or reference was engineering specifications and recognized international consensus standards (e.g., specified vacuum ranges, cycle speeds, battery capacities, biocompatibility definitions by ISO standards).
8. The sample size for the training set:
- Not applicable. This device is not described as involving machine learning from a training set for its core function. The embedded software and app are for control and display, not for learning or prediction based on large datasets.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
FDA 510(k) Clearance Letter - eufy Wearable Breast Pumps
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 11, 2025
Anker Innovations Limited
℅ Tracy Chen
Manager
Shenzhen Joyantech Consulting Co., Ltd.
1713A, Block A, Zhongguan Times Square,
Liuxian Avenue Xili Town
Shenzhen, Guangdong 518000
CHINA
Re: K250207
Trade/Device Name: eufy Wearable Breast Pump S1 (T8DO2); eufy Wearable Breast Pump E10 (T8DO3)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Received: July 11, 2025
Dear Tracy Chen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250207 - Tracy Chen
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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K250207 - Tracy Chen
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive, Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250207
Device Name: eufy Wearable Breast Pump S1 (T8D02)
eufy Wearable Breast Pump E10 (T8D03)
Indications for Use (Describe)
The eufy Wearable Breast Pump S1 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The eufy Wearable Breast Pump E10 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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510(k) Summary- K250207
K250207
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1. Submitter Information
1.1 Applicant information
| Applicant Name | Anker Innovations Limited |
|---|---|
| Address | Unit 56, 8th Floor, Tower 2, Admiralty Centre, 18 Harcourt Road, Hong Kong |
| Tel. | +86 166 2079 6266 |
| Contact person | Darren Li |
| darren.li@anker.com | |
| Date Prepared | August 9, 2025 |
1.2 Contact Information
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square,
Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,
Guangdong Province, China
| Tel. | +86 755-86069197 |
|---|---|
| Contact person | Tracy |
| tracy@cefda.com; grace@cefda.com | |
| Website | http://www.cefda.com |
2. Device information
| Trade name | eufy Wearable Breast Pump S1 (T8DO2)eufy Wearable Breast Pump E10 (T8DO3) |
|---|---|
| Common Name | Powered breast pump |
| Regulation Number | 21 CFR 884.5160 |
| Regulation Name | Powered breast pump |
| Classification Panel | Obstetrics/Gynecology |
| Product code | HGX (Pump, Breast, Powered) |
| Regulatory Class | Class II |
3. Predicate Device Information
| Trade Name | Perifit Pump |
|---|---|
| 510(k) Number | K231785 |
| Product Code | HGX |
| Manufacturer | X6 Innovations |
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The predicate device has not been subject to a design-related recall.
4. Device Description
The eufy Wearable Breast Pump is an electrically powered wearable single breast pump. There are two models, eufy Wearable Breast Pump S1 (T8DO2) and eufy Wearable Breast Pump E10 (T8DO3). S1 consists of a Pump Hub, Diaphragm, Milk Container, Pouring Spout, Heating Pins, Flange, Duckbill Valve and charging pins. E10 consists of Pump Hub, Diaphragm, Milk Container, Pouring Spout, Flange and Duckbill Valve.
The differences between S1 and E10 are as follows:
- E10 has no heating function (S1 has a heating function);
- The charging method is different (S1 for magnetic charging, E10 for Type-C charging).
The eufy Wearable Breast Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1460mAh). The eufy Wearable Breast Pump cannot be operated while it is being charged.
The eufy Wearable Breast Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment. An optional smartphone app may be used with the Breast Pump. The app may be used to control the operation of The Breast Pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Breast Pump.
The eufy Wearable Breast Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.
The eufy Wearable Breast Pump allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 7 vacuum levels, capable of providing suction from -75 to -292.5mmHg, with cycle speeds ranging from 71 to 110 cycles/minute in stimulation mode and 39 to 60 cycles/minute in expression mode.
5. Indication for Use
The eufy Wearable Breast Pump S1 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The eufy Wearable Breast Pump E10 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
6. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Items | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Number | K250207 | K231785 | N/A |
| Device Name | eufy Wearable Breast Pump S1eufy Wearable Breast Pump E10 | Perifit Pump | N/A |
| Model | T8D02: eufy Wearable Breast | / | N/A |
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| Items | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Pump S1T8D03: eufy Wearable Breast Pump E10 | |||
| Indications for Use | The eufy Wearable Breast Pump S1 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.The eufy Wearable Breast Pump E10 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user. | The Perifit Pump is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | Similar |
| Patient Population | Lactating Women | Lactating Women | Identical |
| Single/double pump | Single (or Double by using two units simultaneously) | Single (or Double by using two units simultaneously) | Identical |
| Cycling control Mechanism | Microcontroller | Microcontroller | Identical |
| Backflow Protection | Yes | Yes | Identical |
| Suction Modes | Stimulation Mode and Expression Mode | Stimulation Mode and Expression Mode | Identical |
| Suction levels | 7 | 8 | Similar |
| Adjustable suction levels | Yes | Yes | Identical |
| Flange Size | 15，17，19，21，24，27mm | 18mm, 21 mm, 24 mm, and 27mm | Similar |
| Vacuum range | -75 to -292.5mmHg | -30 to -300 mmHg | Similar |
| Cycle speed: Stimulation | 71 to 110 cycles/minute | 68 to 120 cycles per minute | Similar |
| Cycle speed: Expression | 39 to 60 cycles/minute | 28 to 80 cycles per minute | Similar |
| Controls | Power button, switch between stimulation and expression modes (S1 only), stimulation mode (E10 only), expression mode (E10 only), heating on/off (S1 only), +/- (adjust the suction, heat (S1 only) level, and LR paring (S1 only), LR paring (E10 only) | Power button, +/- (adjust suction intensity), pumping mode and intensity level indicator, switch between stimulation and expression modes | Similar |
| Power Supply | Li-Ion Battery | Li-ion Battery | Identical |
| Indicators | Yes, LED | Yes, LED | Identical |
| Materials | Milk Container: PolypropyleneFlange: SiliconePump Outer Housing: Acrylonitrile Butadiene | Milk-contacting parts are made of silicone, polypropylene, and Tritan copolyester (bottle only)Pump Outer Housing: | Similar |
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| Items | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Styrene (ABS) plastic | PC/ABS plastic | ||
| Software | Pump operates on embedded software.A smartphone app (optional) may also be used to control the pump | Pump operates on embedded software.A smartphone app (optional) may also be used to control the pump | IdenticalSimilar: the smartphone apps for both devices provide similar functionalities and any differences do not raise different questions of safety or effectiveness. |
In comparison to the predicate device, the subject device, eufy Wearable Breast Pump E10 and eufy Wearable Breast Pump S1, has the same intended use and similar indications for use – the expression and collection of breast milk. As seen in the comparison table, the subject and predicate devices have different technological features, including the user interface, vacuum range, cycle speed range, suction levels, materials, and flange size. These technological differences do not raise different questions of safety and effectiveness.
7. Summary of Non-clinical Performance Testing
1) Electrical Safety, Electromagnetic Compatibility
The subject device has passed safety testing in according to following standards.
- ANSI AAMI ES60601-1: 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021]: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133-2 Edition1.0 2017-02: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
2) Performance testing
Performance testing was conducted on the subject device:
- Vacuum Suction pressure & Cycle speed
- Backflow protection
- Battery capacity
- Operating time/charging time
- Use life testing
Device specifications were met for all tests conducted.
3) Packaging simulation testing
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The packaging simulation testing was conducted in accordance with ISTA 3A: 2018.
4) Biocompatibility
Biocompatibility testing was conducted in accordance with the 2023 FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
The subject device has passed biocompatibility testing in according to following standards.
- ANSI AAMI ISO 10993-5:2009/(R)2014: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 First edition 2021-01: Biological evaluation of medical devices - Part 23: Tests for irritation
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
5) Software
The subject device contains an embedded software and a mobile application. Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions."
6) Cybersecurity
The cybersecurity was evaluated according to the 2025 FDA's Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
8. Conclusions
The results of the performance testing described above demonstrate that the subject device, eufy Wearable Breast Pump S1, eufy Wearable Breast Pump E10 is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).