The Spectra Platinum is an electrically powered breast pump intended for use by lactating women to stimulate lactation and express breast milk. The device is intended for single-user, home use. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time.

The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).

The Spectra Platinum is comprised of the following components: Main unit, Power adapter, Tubing, Backflow protector, Wide breast shield, Milk bottle, Screw ring, Cap, Sealing cap for milk bottle, Silicone nipple, Silicone valve. The device is provided non-sterile.

The Spectra Platinum support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

Spectra Platinum includes the following features:

Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra Platinum operates within these specified parameters.

When the backflow protector is assembled between the pump unit and the wide breast shield, the silicone membrane inside the backflow protector creates a hygienic barrier by preventing air and milk from flowing back into the pump unit. This not only enables safe and hygienic breast pumping, but also protects the pump unit from contamination and potential damage caused by backflow of milk.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Spectra Platinum Breast Pump

Page 1

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

Doc ID # 04017.08.02

November 21, 2025

Uzinmedicare Co., Ltd.
Soyeon Lim
Researcher
56, Dongtansandan 5-gil, Hwaseong-si
Gyeonggi-do, 18487
KOREA, SOUTH

Re: K251932
Trade/Device Name: Spectra Platinum
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: June 20, 2025
Received: June 24, 2025

Dear Soyeon Lim:

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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

Page 2

K251932 - Soyeon Lim
Page 2

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

Page 3

K251932 - Soyeon Lim
Page 3

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: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K251932
Device Name: Spectra Platinum

Indications for Use (Describe)

The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

K251932

1. Submitter Information

Applicant: Uzinmedicare Co., Ltd.
Contact: Soyeon Lim
Phone: +82-70-5228-1466
Email: soyeon.lim@uzinmedicare.com
Address: 56, Dongtansandan 5-gil, Hwaseong-si,
Gyeonggi-do, Republic of Korea
[Zip.18487]

2. Correspondent Information

Contact: Soyeon Lim
Phone: +82-70-5228-1466
Email: soyeon.lim@uzinmedicare.com

3. Date prepared: November 21, 2025

4. Device Information

Device Trade Name: Spectra Platinum
Common Name: Powered breast pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product Code: HGX (Pump, Breast, Powered)
Regulatory Class: II

5. Predicate Device Information

Device Name: Spectra S1Plus and Spectra S2 Plus
510(k) Number: K150476
Manufacturer: Uzinmedicare Co., Ltd.

The Predicate Device has not been subject to a design-related recall.

6. Device Description

The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).

Page 6

Spectra Platinum includes the following features:

Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra Platinum operates within these specified parameters.

7. Indications for Use

The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

8. 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.

Table 1: Comparator Table for Subject, Predicate Device

	Subject Device	Predicate Device(K150476)
General Device characteristics
Trade/Model name	Spectra Platinum	Spectra S1 Plus and Spectra S2 Plus
Product Code	HGX	HGX
Manufacturer	Uzinmedicare Co., Ltd.	Uzinmedicare Co., Ltd.
Regulation No.	21 CFR 884. 5160	21 CFR 884. 5160
Device Class	II	II
Patient Population	Lactating Women	Lactating Women
Indication for Use	The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.	The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
Specifications
Pump Type	Diaphragm	Diaphragm
Pump Options	Single or Double	Single or Double
Suction Levels	Expression Mode: 15 LevelsMassage Mode: 5 Levels	Expression Mode: 12 LevelsMassage Mode: 5 Levels
Suction Strength	Expression : 90-270 mmHgMassage Mode : 60-100 mmHg	Expression:50-270 mmHgMassage Mode: 50-130 mmHg
Cycle Speed	Expression : 38-54 cycles/minMassage : 70-105 cycles/min	38-70 cycles/min (adjustable)

Page 7

	Subject Device	Predicate Device(K150476)
Visual Indicator	OLED	LCD
Power Supply (Conventional Outlet)	AC/DC wall converter-Input: AC 100-240 V, 50/60 Hz-Output: DC12 V 2 A	AC/DC wall converter-Input: AC 100-240 V, 50/60 Hz-Output: DC12 V 2 A
Power Supply (Battery)	Rechargeable Lithium Ion Battery11.1V 2,000mAh Li-Polymer	Rechargeable Lithium Ion Battery(only for Spectra S1 Plus)11.1V 2,000mAh Li-Polymer
Back Flow Protection	Yes	Yes

The indications for use of the subject and predicate devices are identical, and they have the same intended use – the expression and collection of breast milk from lactating women.

There are different technological characteristics between the subject and predicate device, including differences in suction level, suction strength, and cycle speed. These differences do not raise different questions of safety or effectiveness.

9. Summary of Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.

Biocompatibility

Per the 2023 FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical – Part 1: Evaluation and testing within a risk management process", the following tests were performed on the direct user contacting device materials:

Cytotoxicity / ISO 10993-5:2009
Sensitization / ISO 10993-10:2010
Irritation / ISO 10993-10:2010

The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

Electrical Safety

Electrical safety testing was conducted in accordance with:

IEC 60601-1:2005 + A1:2012 + A2:2020 (3.2 Edition) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015+A1:2020 (2.1 Edition) 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 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.
IEC 62471:2006 Photobiological safety of lamps and lamp systems

Electromagnetic Compatibility (EMC)

EMC testing was conducted in accordance with:

IEC 60601-1-2:2014 + AMD 1:2020 Medical electrical equipment - Part 1-2: General requirements

Page 8

for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC TR 60601-4-2:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.

Software

Software verification and validation consistent with a basic level of concern was provided per the 2023 FDA guidance document, Content of Premarket Submissions for Software Functions.

Performance Testing

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
Use-life performance testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

10. Conclusion

The results of the performance testing described above demonstrate that Spectra Platinum is as safe and effective as the predicate device and reference device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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).