Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

Device Description

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Criteria	Acceptance Criteria	Reported Device Performance
Saturation Accuracy, No Motion (70-100%)	±3%	±3%
Pulse Rate Accuracy, No Motion	±2 bpm (30-250 bpm)	±2 bpm (30-250 bpm)
Biocompatibility	Pass ISO 10993 cytotoxicity, skin irritation, and skin sensitivity tests	Pass ISO 10993 cytotoxicity, skin irritation, and skin sensitivity tests

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
- Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.
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:
- Not applicable. This device is a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.
The type of ground truth used:
- Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.
The sample size for the training set:
- Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

FDA 510(k) Clearance Letter - Unimed Reusable SpO2 Sensors

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 13, 2025

Unimed Medical Supplies, Inc.
Huanyu Zeng
Regulatory affairs specialist
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan District
Shenzhen, China

Re: K250931

Trade/Device Name: Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121);

Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA
Dated: July 17, 2025
Received: July 17, 2025

Dear Huanyu Zeng:

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.

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K250931 - Huanyu Zeng Page 2

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.

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-

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K250931 - Huanyu Zeng Page 3

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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,

Bradley Q. Quinn -S

Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250931

Please provide the device trade name(s).

Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117);
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117);
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121);
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Unimed Reusable SpO2 Sensors (-117 and -121 Series) Page 8 of 53

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510K Summary

1. Submitter

Date Prepared: March 28, 2025
Submitter/Manufacturer: Unimed Medical Supplies Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan District, Shenzhen, China 518108
FDA Establishment Number: 3007307487
Contact: Zeng Huanyu
RA Specialist
Tel: +86-755 26695165
E-mail: zenghy@unimed.cn
510(k) Submission Type: This is a Traditional 510(k).

2. Proposed Device

Trade Name: Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117)
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121)
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
Common Name: Oximeter Sensor
Model Numbers: U403-117, U103-117, U410-121, U110-121
Classification: Medical Specialty: Cardiovascular
Regulation: 21 CFR 870.2700 – Oximeter
Product Code: DQA
Class: II

3. Predicate Device

Predicate Device
510(K) No.	Trade Name
K093881	TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR

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Reference Device
510(K) No.	Trade Name
K151063	Monitor B40

4. Device description

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

5. Intended use/Indications for use

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6. Comparison to predicate devices

Feature	Subject Device (Model: U403-117, U103-117, U410-121, U110-121)	Predicate Device (K093881)	Comparison to Predicate/Reference Devices
General Information
Device name	Unimed Reusable SpO2 Sensors	TruSignal® SpO2 Sensors and Interconnect Cables	/
Classification Regulation/ Product Code	21 CFR 870.2700, Class II/DQA	21 CFR 870.2700, Class II/DQA	Identical
Intended use/Indications for use	Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.	TS-F-D The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds) TS-E-D The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds)	Substantially equivalent

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Feature	Subject Device (Model: U403-117, U103-117, U410-121, U110-121)	Predicate Device (K093881)	Comparison to Predicate/Reference Devices
		TS-W-D The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 66 pounds) TS-SE-3 The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range All patients TS-AF-10 and TS-AF-25 The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range

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Feature	Subject Device (Model: U403-117, U103-117, U410-121, U110-121)	Predicate Device (K093881)	Comparison to Predicate/Reference Devices
		All patients Trusignal SpO2 Interconnect cables The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.
Principle of operation	Two-wavelength relative optical absorption	Two-wavelength relative optical absorption	Same
Key performance specifications/ characteristics
Intended patient population	Adult/Pediatric	TS-F-D: Patient weight range > 20 kg TS-E-D: Patient weight range > 10 kg TS-W-D: Patient weight range > 3 kg	Substantially equivalent
Intended application site	Finger	TS-F-D: Finger, toe TS-E-D: Ear TS-W-D: Finger, toe, palm of the hand, side of the foot	Substantially equivalent
Prescription or OTC	Rx Only	Rx Only	Identical
Use type	Reusable	Reusable	Identical
Sensor Structure Composition	Sensor connector, cable, LED	Sensor connector, cable, LED&PD,	Substantially equivalent¹

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Feature	Subject Device (Model: U403-117, U103-117, U410-121, U110-121)	Predicate Device (K093881)	Comparison to Predicate/Reference Devices
	(660nm/880nm/940nm) &PD, finger clip	finger clip/ear clip/wrap
Performance (Arms)
Saturation Accuracy, No Motion (70-100%)	±3%	±2%	Substantially equivalent²
Pulse Rate Accuracy, No Motion	±2 bpm (30-250 bpm)	±2 bpm (30 to 250 bpm)	Substantially equivalent³
Environmental
Operating Temperature	5 to 40 °C	-40° to 60°C	Substantially equivalent
Operational/Storage Humidity	10 to 85%	5 to 95%	Substantially equivalent
Biocompatibility	Pass ISO 10993 cytotoxicity, skin irritation and skin sensitivity tests	Pass ISO 10993 cytotoxicity, skin irritation and skin sensitivity tests	Identical
Energy source	Monitor power supply	Monitor power supply	Identical

Note:

Subject devices have passed biocompatibility testing, with qualified bench testing and clinical testing results. Therefore, sensor structure composition is considered substantially equivalent.
Both Subject Device and Predicate Device have met the SpO2 accuracy per Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff and are therefore considered substantially equivalent.
According to the requirements of "201.12.1.104 Pulse rate ACCURACY" of ISO 80601-2-61:2017, both Subject Device and Predicate Device have validated accuracy over the claimed pulse range and are therefore considered substantially equivalent.

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7. Verification and validation testing

Non-clinical test data

Non-clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The conducted non-clinical tests conformed to the following the recognized standards:

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020)
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014+AMD1:2020)
ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, COR1: 2018)
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation

The subject sensors include finger clip housing and silicone pad as patient-contacting components. The type of contact is contact with intact skin and the contact duration is defined as prolonged exposure per ISO 10993-1:2018 (medical devices whose cumulative sum of single, multiple or repeated contact time is likely to exceed 24 h but not exceed 30 d). Therefore, our biocompatibility testing has been specifically designed to meet the corresponding endpoint assessment requirements, including the following tests:

Cytotoxicity
Skin sensitization
Skin irritation

The results of these tests demonstrate the biocompatibility of the subject devices.

Clinical test data

A clinical study was conducted under an approved protocol with subject informed consent to determine the accuracy of proposed device. The clinical studies were conducted per following standards:

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ISO 80601-2-61 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff

Clinical hypoxia test results were obtained in human adult volunteers (the study population includes sufficient darkly pigmented subjects) to validate the accuracy of the subject devices versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Twelve subjects were enrolled for the clinical study. The Fitzpatrick Scale was used to determine their skin pigmentation scores. Three dark subjects (Fitzpatrick Type 5-6) in this study allow a proper evaluation of the sensor accuracy in dark population. The study contains more than the minimum 200 data points, and the clinical study results support device accuracy claims for the specified saturation range.

8. Substantial Equivalence Statement

Based on the comparison, analysis, and the submitted verification and validation data, Unimed believes that the Unimed Reusable SpO2 Sensors are as safe and effective and are substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).