Spectra S1 Pro; Spectra S2 Pro

K251423 · Uzinmedicare Co., Ltd. · HGX · Feb 6, 2026 · Obstetrics/Gynecology

Device Facts

• Record ID: K251423
• Device Name: Spectra S1 Pro; Spectra S2 Pro
• Applicant: Uzinmedicare Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Feb 6, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

Device Story

Spectra S1 Pro and S2 Pro are tabletop, single-user powered breast pumps; used by lactating women to express/collect milk. Device features dual-phase operation (Massage and Expression modes); user adjusts vacuum levels and cycle speeds via button controls and LCD interface. S1 Pro includes rechargeable Li-Polymer battery; S2 Pro is AC-powered. System includes pump unit, breast shield, back-flow protector, tubing, silicone valve, and collection bottle. Back-flow protector provides physical barrier preventing milk/air ingress into pump unit. Device enables single or double pumping. Healthcare provider/user monitors output via visual inspection of collected milk; device performance ensures consistent suction parameters to facilitate milk expression, supporting breastfeeding goals.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (cytotoxicity, sensitization, irritation), electrical safety (ANSI/AAMI ES60601-1, IEC 62133-2, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and performance testing (vacuum verification, backflow protection, use-life, and battery performance).

Technological Characteristics

Tabletop diaphragm pump; AC/DC power or Li-Polymer battery. Milk-contacting components compliant with 21 CFR 177. Features LCD and button-controlled microcontroller for vacuum/cycle adjustment. Vacuum range: 50-270 mmHg (Expression), 50-180 mmHg (Massage). Cycle speeds: 38-58 cpm (Expression), 70-105 cpm (Massage). Non-sterile. Software evaluated at Basic Documentation level.

Indications for Use

Indicated for lactating women requiring expression and collection of breast milk. No specific contraindications listed.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Spectra S1Plus and Spectra S2 Plus (K150476)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

February 6, 2026

Uzinmedicare Co., Ltd.
% Jong-Hyun Kim
CEO
GMSC Co., Ltd
66, Cheongcho-ro, Deogyang-gu, Goyang-si
Gyeonggi-do, 10543
KOREA, SOUTH

Re: K251423
Trade/Device Name: Spectra S1 Pro; Spectra S2 Pro
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: January 6, 2026
Received: January 6, 2026

Dear Jong-Hyun Kim:

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, Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

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

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K251423 - Jong-Hyun Kim
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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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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 ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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) K251423 | |
| Device Name Spectra S1 Pro; Spectra S2 Pro | |
| Indications for Use (Describe) The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps 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 [e-mail] | |
| "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." | |

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K251423
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510(k) Summary – K251423

1. Submitter Information
Applicant: Uzinmedicare Co., Ltd.
Contact: Soyeon Lim
Email: [e-mail]
Phone: [phone]
Address: 56, Dongtansandan 5-gil, Hwaseong-si,
Gyeonggi-do, Republic of Korea
[Zip.18487]

2. Correspondent Information
Contact: Jong-Hyun Kim
CEO
Firm: Global Medical Standard Consulting Co.
Ltd.
Phone: [phone]
Email: [e-mail]

3. Date prepared: February 5, 2026

4. Device Information
Device Name: Spectra S1 Pro; Spectra S2 Pro
Common Name: Powered Breast Pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product Code: HGX (Pump, Breast, Powered)
Regulatory Class: 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 S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Spectra S1 Pro and Spectra S2 Pro are comprised of the following components: pump unit, adapter, wide breast shield, back-flow protector, tubing, silicone valve, bottle cap, bottle screw, nipple, airtight cap, and PP bottle. The device is provided non-sterile.

The Spectra S1 Pro and Spectra S2 Pro 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 S1 Pro and Spectra S2 Pro includes the following features:

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- Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
- Expression mode: 1-15 level (50-270 mmHg), cycle speeds (38, 42, 46, 50, 52, 58)
- Massage mode: 1-5 level (50-180 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra S1 Pro operates using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2000mAh). The Spectra S2 Pro operates using an AC adapter (100-240V AC, 50/60Hz, DC 12V) only.

When the backflow protector is assembled between the pump unit and the breast shield, the silicone membrane inside the backflow protector creates a physical barrier by preventing air and milk from flowing back into the pump unit.

All milk contacting components are compliant with 21 CFR 177.

## 7. Indications for Use

The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps 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 and Predicate Devices

| | Spectra S1 Pro; Spectra S2 Pro K251423 Subject Device | Spectra S1 Plus; Spectra S2 Plus K150476 Predicate Device | Comparison |
| --- | --- | --- | --- |
| Product Name | Spectra S1 Pro; Spectra S2 Pro | Spectra S1 Plus; Spectra S2 Plus | N/A |
| Code | HGX | HGX | Same |
| Indications for use | The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps 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. | Same |
| Single User | Yes | Yes | Same |
| Single/double pump | Single or double | Single or double | Same |
| Pump Type | Tabletop diaphragm | Tabletop diaphragm | Same |
| Media separation (backflow protection) | Yes | Yes | Same |
| Cycling control mechanism | Microcontroller | Microcontroller | Same |
| User Interface | LCD, button controls | LCD, button controls | Similar |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Power supply (with | AC/DC wall converter | AC/DC wall converter | Same |

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| adaptor) | -Input: AC 100-240V, 50/60Hz
-Output: DC12V 2A | -Input: AC 100-240V, 50/60Hz
-Output: DC12V 2A | |
| --- | --- | --- | --- |
| Power supply
(internally powered) | S1 Pro: Rechargeable Lithium Ion Battery
11.1V 2,000mAh Li-Polymer | S1 Plus: Rechargeable Lithium Ion Battery
11.1V 2,000mAh Li-Polymer | Same |
| Suction levels
(Massage) | 50-180 mmHg | 50-130 mmHg | Different |
| Suction levels
(Expression) | 50-270 mmHg | 50-270 mmHg | Same |
| Cycles per minute
(Massage) | 70 to 105 cpm | 38 to 70 cpm | Different |
| Cycles per minute
(Expression) | 38 to 58 cpm | 38 to 70 cpm | Different |
| Suction levels | 15 Levels for expression, 5 levels for massage | 12 Levels for expression, 5 levels for massage | Different |
| Adjustable Suction Levels | Yes | Yes | Same |
| Mobile Application | No | No | Same |
| Design | Tabletop pump with separated pump and Flange | Tabletop pump with separated pump and Flange | Same |

The indications for use of the subject and predicate devices are identical, and both devices have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).

The subject and predicate devices have similar technological features, including tabletop design, power supply, and user interface. However, as shown in the table above, there are technological differences between the subject and predicate devices, including different overall vacuum/cycle specifications and available modes. The different technological characteristics of the subject devices, as compared to the predicate device, do not raise different questions of safety and effectiveness.

## 9. Summary of Non-Clinical Performance Testing

### 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)
- Skin Sensitization (ISO 10993-10:2010)
- Skin Irritation (ISO 10993-10:2010)

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

### Electrical Safety

Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), IEC 62133-2:2017, 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, and IEC 60601-1-11:2015 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.

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## Electromagnetic Compatibility

Testing was conducted in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: "General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."

## Software

Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device 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 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 S1 Pro and Spectra S2 Pro are as safe and effective as the predicate device and support a determination of substantial equivalence.