Electric Breast Pump (HL-3058, F5112)

K252629 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · HGX · Oct 27, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K252629
• Device Name: Electric Breast Pump (HL-3058, F5112)
• Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Oct 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

Device Story

Electric breast pump; diaphragm-type vacuum pump; software-controlled suction pressure and cycle speed. Input: user-selected settings via five-dimensional navigation button. Output: vacuum suction for milk expression; includes 'hot function' for neck warmth. Used in home environment by lactating women. Device provides voice prompts instead of visual display. Benefits: facilitates milk expression for breastfeeding mothers.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1 series, IEC 62133-2), software verification/validation, vacuum range/cycle speed performance, backflow prevention, battery performance, and use-life testing.

Technological Characteristics

Powered diaphragm vacuum pump; Li-Ion battery; PP, TPE, ABS, PC+ABS, and solid silicone materials. Connectivity: None. Software: Embedded firmware for pump control. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, ISO 10993. Form factor: Handheld/portable.

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for single-user, home-use environments.

Regulatory Classification

Identification

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

Predicate Devices

• Electric Breast Pump (F5055) (K240218)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 27, 2025

Fimilla (Shanghai) maternity & baby Articles Co., Ltd
% Youshan Gong
RA Specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center,
No. 3101-90 Qianhai Road
Shenzhen, Guangdong 518052
CHINA

Re: K252629
Trade/Device Name: Electric Breast Pump (HL-3058, F5112)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: July 25, 2025
Received: August 20, 2025

Dear Youshan Gong:

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.

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

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K252629 - Youshan Gong
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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 (6/20)
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: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252629 | |
| Device Name Electric Breast Pump (Models HL-3058, F5112) | |
| Indications for Use (Describe) The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for 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. | |
| 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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Fimilla (Shanghai) maternity & baby Articles Co., Ltd
510(k) Summary
K252629
Page 1 of 6

# 510(k) Summary of K252629

"510(k) Summary" as required by 21 CFR Part 807.92.

Date Prepared: October 21, 2025

# I. Submitter

Fimilla (Shanghai) maternity & baby Articles Co., Ltd
No. 65 Lane 3029 HuaXu Road, HuaXin Town QingPu District, Shanghai, China
Post code: 201799
Tel.: [phone]

Shulin Wu
General Manager
Tel: [phone]
E-mail: [e-mail]

# II. Device

Name of Device: Electric Breast Pump (Models HL-3058, F5112)
Common or Usual Name: Powered breast pump
Regulation Name: Powered Breast Pump
Regulation Number: 21 CFR 884.5160
Regulatory Class: II
Product Code: HGX (Powered, Breast, Pump)

# III. Predicate Device

Predicate device:

| Manufacturer | Predicate Device | 510(k) Number |
| --- | --- | --- |
| Fimilla (Shanghai) maternity & baby Articles Co., Ltd | Electric Breast Pump (F5055) | K240218 |

The predicate device has not been subject to a design-related recall.

# IV. Device Description

The Electric Breast Pump (Models HL-3058, F5112) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device

Page 1 of 6

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Kimilla (Shanghai) maternity & baby Articles Co., Ltd
510(k) Summary
K252629
Page 2 of 6

to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.

Electric Breast Pump (Models HL-3058, F5112) also has a hot function which provides hear to the users neck for warmth. It does not affect the intended use of the product.

The following patient-contacting materials are used in the subject device:

| Model | Contacted Component Name | Materials | Body Contact Category | Contact Duration |
| --- | --- | --- | --- | --- |
| HL-3058, F5112 | Breast shield | PP | Surface-contacting device: Intact skin | Less than 24 hours |

Detailed device specifications can be found in the comparison chart below.

## V. Indications for Use

The Electric Breast Pump (Models: HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

## VI. 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.

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 510(k) Number | K252629 | K240218 | / |
| Trade name | Electric Breast Pump (Models HL-3058, F5112) | Electric Breast Pump (F5055) | / |
| Manufacturer | Kimilla (Shanghai) maternity & baby Articles Co., Ltd | Kimilla (Shanghai) maternity & baby Articles Co., Ltd | / |
| Regulation | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |

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510(k) Summary
K252629
Page 3 of 6

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| number | | | |
| Product code | HGX | HGX | Same |
| Device classification | Class II | Class II | Same |
| Indication for use/ Intended use | The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user. | The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user. | Same |
| Prescription or OTC | OTC | OTC | Same |
| Pump Options | Single, Double | Single, Double | Same |
| Provide Non-sterile | Yes | Yes | Same |
| Re-usable | Yes | Yes | Same |
| Direct user contact | Yes | Yes | Same |
| Backflow Protection | Yes | Yes | Same |
| Suction Modes | Expression Mode
Empty Mode
Hot Function Mode | Massage mode
Expression mode
Soothing mode | Different |
| Suction levels | 6 | 9 | Different |
| Adjustable suction levels | Yes | Yes | Same |

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510(k) Summary
K252629
Page 4 of 6

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Vacuum range: | 40 to 280 ±5 mmHg | 70 to 280 ±5 mmHg | Similar |
| Cycle Speed: | 20 to 85 ±2 cycles/minute | 20 to 135 ±2 cycles/minute | Similar |
| Controls | Five - dimensional navigation button: Power/Voice button, Mode button, Hot function button, Levels increase/ decrease button | Key panel | Different |
| Indicator | None, there is a voice prompt function. | Yes. General display | |
| Power Supply | Li-Ion Battery | Li-Ion Battery | Same |
| Materials | Milk collection bottle: PP+TPE
Breast shield: PP
Pump unit: ABS, PC+ABS, Solid Silicone | Not publicly available | Similar |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| Electrical safety | IEC 60601-1
IEC 60601-1-2
IEC TS 60601-4-2
IEC 60601-1-11
IEC 62133-2 | Not publicly available | Similar |
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | Same |

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K252629 Page 5 of 6

| Comparison Elements | Subject Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| | ISO 10993-10
ISO 10993-23 | ISO 10993-10 | |

The indications for use of the subject and predicate devices are similar, and both devices have the same intended use (i.e., for collection of breast milk from the breasts of lactating women). The technological differences between the subject and predicate devices are the modes, including a hot function mode, materials, controls, suction strength, and cycle speed. These differences do not raise different questions of safety and effectiveness.

# VII. Summary of Non-Clinical Performance Testing

## 1) Biocompatibility Testing

The biocompatibility evaluation for the patient-contacting components of the Electric Breast Pump (Models HL-3058, F5112) was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process".

## 2) Electrical Safety and EMC

Electrical safety and EMC testing was performed per the following standards:

- IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment –Part 1: 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

## 3) Software Verification and Validation

Software verification and validation consistent with a basic level of concern was provided per the FDA 2023 guidance document "Content of Premarket Submissions for Device Software Functions". System validation testing presented in this 510(k) demonstrated that

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Kimilla (Shanghai) maternity & baby Articles Co., Ltd 510(k) Summary

K252629 Page 6 of 6

all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.

## 4) Additional Non-Clinical Testing

Vacuum range and cycle speed of subject devices were tested. All the test results complied with the design specifications of the subject device throughout the use life.

Backflow testing was conducted to ensure that no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor. The test results showed that there was no backflow during the test.

Battery performance testing was conducted to demonstrate that the battery remains functional during its stated use-life.

Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

Use-life testing was conducted to demonstrate the device maintained it's specifications throughout the use-life of the device.

## VIII. Conclusions

The results of the performance testing described above demonstrate that the Electric Breast Pump (Models HL-3058, F5112) is as safe and effective as the predicate device and supports a determination of substantial equivalence.