Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Device Facts
| Record ID | K260346 |
|---|---|
| Device Name | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) |
| Applicant | Polybell (Guangzhou) Limited |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Jun 12, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
Indications for Use
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
Device Story
Electric breast pump; diaphragm-type vacuum pump; software-controlled suction pressure and cycle speed. Input: user-selected settings (mode, vacuum level, cycle speed). Output: rhythmic vacuum suction for milk expression. Used in home environment by lactating women. Device includes various models with single or double pumping capabilities, multiple suction modes (stimulation, expression, massage, auto), and adjustable vacuum levels. Healthcare provider does not operate; patient self-use. Benefits: facilitates milk expression for lactating women. Output affects clinical decision-making by enabling milk collection for infant feeding.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993), electrical safety/EMC (IEC 60601 series), software verification/validation, vacuum range/cycle speed performance, backflow prevention, and battery life testing.
Technological Characteristics
Powered diaphragm-type vacuum pump. Materials: PP, Silicone, ABS. Connectivity: None. Power: Li-Ion battery or AC adapter. Software-controlled vacuum pressure and cycle speed. Biocompatibility per ISO 10993-5, -10, -23. Electrical safety per IEC 60601-1, 60601-1-2, 60601-1-11, 60601-4-2, 62133-2.
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
- Wearable Breast Pump (FS12A, FS12B) (K250843)
Submission Summary (Full Text)
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 12, 2026
Polybell (Guangzhou) Limited
% Axiu Yang
RA Engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center
# 3101-90 Qinahai Rd.
Shenzhen, Guangdong 518052
CHINA
Re: K260346
Trade/Device Name: Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: January 30, 2026
Received: February 3, 2026
Dear Axiu Yang:
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
{1}
K260346 - Axiu Yang
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
{2}
K260346 - Axiu Yang
Page 3
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K260346
Device Name
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Indications for Use (Describe)
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device 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.
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
{4}
K260346
Page 1 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion---
# 510(k) Summary-K260346
**'510(k) Summary' as required by 21 CFR Part 807.92.**
Date Prepared: June 12, 2026
## I. Submitter
POLYBELL (GUANGZHOU) LIMITED
No.50, West Street, Xihu Village, Renhe Town, Baiyun District, Guangzhou, Guangdong, 510470, China
Post code: 510470
Tel.: 0086-020-66617288
Qingliang Xu
General Manager
Tel: +86 135 3170 6381
E-mail: baodadqb@gzboda.com
## II. Device Information
Device Name: Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Common Name: Powered breast pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product Code: HGX (Powered, Breast, Pump)
Regulatory Class: II
## III. Predicate Device
| Manufacturer | Predicate Device | 510(k) Number |
| --- | --- | --- |
| Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (FS12A, FS12B) | K250843 |
The predicate device has not been subject to a design-related recall.
## IV. Device Description
The Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129,
Page 1 of 9
{5}
K260346
Page 2 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion
H1128, H620, H705, H706) 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 to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
The following patient-contacting materials are used in the subject device:
| Model | Component name | Material of Component | Body Contact Category | Contact Duration |
| --- | --- | --- | --- | --- |
| BH627 | Silicone horn cover | Silicone | Surface-contacting device: Intact skin | Less than 24 hours |
| BH628 | Silicone horn cover | Silicone | | |
| BH707, BH709 | Silicone horn cover | Silicone | | |
| BH813 | Tee Type-A | PP | | |
| | 626/816 Silicone horn cover | Silicone | | |
| BH816 | Tee Type-A | PP | | |
| | 626/816 Silicone horn cover | Silicone | | |
| BH110 | Silicone horn cover | Silicone | | |
| H701 | H618 Sanitary Tee | PP | | |
| | Reducer | Silicone | | |
| H1128, H1129 | H1129 Silicone horn cover, Reducer | Silicone, Silicone | | |
| H620 | H618 Sanitary Tee | PP | | |
| | Reducer | Silicone | | |
| H705, H706 | H705 Silicone horn cover, Reducer | Silicone | | |
Detailed device specifications can be found in the comparison chart below.
### V. Indications for Use
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a 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.
Page 2 of 9
{6}
K260346
Page 3 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion---
| Comparison Elements | Subject Devices K260346 | Predicate Device K250843 | Remarks |
| --- | --- | --- | --- |
| Trade name | Electric Breast Pump | Wearable Breast Pump | / |
| Model | BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706 | FS12A, FS12B | |
| Manufacturer | POLYBELL (GUANGZHOU) LIMITED | Shenzhen TPH Technology Co., Ltd. | / |
| Regulation number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Product code | HGX | HGX | Same |
| Device classification | Class II | Class II | Same |
| Indication for use/ Intended use | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user. | The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user only. | Same |
| Prescription or OTC | OTC | OTC | Same |
| Pump Options | H701: Double BH627, BH816, BH110, H1129, H1128, H620, H705, H706: Single BH628, BH707, BH709, BH813: Single and Double | Single | Same |
| Direct user contact | Yes | Yes | Same |
| Backflow Protection | Yes | Yes | Same |
| Suction Modes | BH627, BH816, BH110: Stimulation mode, Expression mode | Stimulation Mode, Expression Mode, | Different |
Page 3 of 9
{7}
K260346
Page 4 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion
| | BH628, BH707, BH709, BH813: Single/Double Stimulation Mode, Single/Double Expression Mode H1129, H1128, H705, H706: Stimulation Mode, Expression Mode, Massage mode, Auto Mode H620: Stimulation Mode, Expression Mode, Massage mode H701: Alternating stimulation mode, Simultaneous expression mode, Alternating expression mode | Auto Mode | |
| --- | --- | --- | --- |
| Suction levels | BH816, H701, H1129, H1128, H620, H705, H706: 12 BH628, BH707, BH709, BH813, BH110: 9 BH627: 6 | 12 | Different |
| Adjustable suction levels | Yes | Yes | Same |
| Vacuum range: | All models single and double pumping: Stimulation mode: 60~180 (mmHg)±15mmHg Expression mode: 80~240 (mmHg)±15mmHg Massage Mode: 80~240 (mmHg)±15mmHg Auto mode: 80~240 (mmHg)±15mmHg | Stimulation Mode: 40~160 (mmHg)±5mmHg Expression Mode: 120~245(mmHg)±5mmHg Auto mode: 40~245 (mmHg)±5mmHg | Different |
| Cycle Speed: | BH627: Simulation mode: 62~154 (cycles/min) ±5cycles/min Expression mode: 27~120 (cycles/min) ±5cycles/min BH628: Simulation mode: Single: 56~153 (cycles/min) ±5cycles/min Double: 28~81 (cycles/min) ±5cycles/min | Stimulation Mode: 75~133 (cycles/min) ±2cycles/min Expression Mode: 21~98 (cycles/min) ±2cycles/min Auto Mode: 21~150 (cycles/min) ±2cycles/min | Different |
Page 4 of 9
{8}
K260346
Page 5 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion
| | Expression mode: Single: 24~82 (cycles/min) ±5cycles/min Double: 16~64 (cycles/min)±5cycles/min BH707/BH709: Stimulation Mode: Single: 56~160 (cycles/min) ±5cycles/min Double: 28~76 (cycles/min) ±5cycles/min Expression Mode: Single: 23~82 (cycles/min) ±5cycles/min Double: 15 ~ 57.5 (cycles/min)±5cycles/min BH813: Stimulation Mode: Single: 60~104 (cycles/min) ±5cycles/min Double: 38~79 (cycles/min) ±5cycles/min Expression mode: Single: 37~74 (cycles/min) ±5cycles/min Double: 22~52 (cycles/min)±5cycles/min BH816: Simulation mode: 71~106 (cycles/min) ±5cycles/min Expression mode:36~56 (cycles/min)±5cycles/min BH110: Simulation mode:56~160 (cycles/min) ±5cycles/min Expression mode: 23~82 (cycles/min) ±5cycles/min H701: Alternating stimulation mode: 50~150 (cycles/min) ±5cycles/min Simultaneous expression mode: 24~66 | | |
| --- | --- | --- | --- |
Page 5 of 9
{9}
K260346
Page 6 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion
| | (cycles/min) ±5cycles/min Alternating expression mode: 19~39 (cycles/min)±5cycles/min H1129/H1128: Stimulation Mode: 79~187 (cycles/min) ±5ycles/min Expression Mode: 31~77 (cycles/min) ±5ycles/min Massage Mode: 30~41 (cycles/min) ±5ycles/min Auto Mode: 79~187 (cycles/min) ± 5ycles/min H620: Stimulation Mode: 64~166 (cycles/min) ±5ycles/min Expression Mode: 30~64 (cycles/min) ±5cycles/min Massage Mode: 30~43 (cycles/min) ±5ycles/min H705/H706: Stimulation Mode: 60~122 (cycles/min) ±5ycles/min Expression Mode: 33~71 (cycles/min) ±5cycles/min Massage Mode: 30~41 (cycles/min) ±5ycles/min Auto Mode: 60~122 (cycles/min) ± 5ycles/min | | |
| --- | --- | --- | --- |
| Controls | BH627, BH707, BH709, BH813, BH816, H701, H1129, H1128, H620, H705, H706: Power button, Mode button, Level increase button and Level reduction button. BH110, BH628: Power button, Mode button, Level increase button, Level reduction and Night light power button | On-Off switch, vacuum adjustment, mode change/power | Same |
Page 6 of 9
{10}
K260346
Page 7 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion
| Indicator | BH628, BH707, BH709, BH813, BH816: LCD BH627, BH110, H701, H1129, H1128, H620, H705, H706: LED | Yes, LED | Same |
| --- | --- | --- | --- |
| Power Supply | BH627, BH628, BH707, BH709, BH110: Li-Ion Battery and AC adapter BH813, BH816: AC adaptor H701, H1129, H1128, H620, H705, H706: Li-Ion Battery | Li-Ion Battery | Different |
| Materials | PP, Silicone, ABS | Not publicly available | Different |
| 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 | IEC 60601-1 IEC 62133-2 IEC 60601-1-11 IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | Same |
The indications for use of the subject and predicate device are identical, 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 device are the modes, suction levels, vacuum pressure, power supply, material and cycle speed. These differences do not raise different questions of safety and effectiveness and can be addressed through performance testing.
Page 7 of 9
{11}
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion
K260346
Page 8 of 9
## VII. Summary of Non-Clinical Performance Testing
### 1) Biocompatibility Testing
The biocompatibility evaluation for the patient-contacting components of the Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)) was conducted in accordance with Attachment G of the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process'" dated September 2023.
### 2) Electrical Safety and EMC
Electrical safety and EMC testing was performed per the following standards:
- ➤ IEC 60601-1-2: 2014+A1: 2021 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- ➤ IEC 60601-4-2: 2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- ➤ IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ➤ IEC 60601-1-11: Edition 2.1 2020-7 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: Edition 1.1 2021-7 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 documentation level 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 all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.
### 4) Non-Clinical Performance 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.
Page 8 of 9
{12}
K260346
Page 9 of 9
POLYBELL (GUANGZHOU) LIMITED
Substantial Equivalence Discussion---
Use-life testing was conducted to demonstrate the device maintained it's specifications throughout the use-life of the device.
### VIII. Conclusion
The results of the performance testing described above demonstrate that the Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Page 9 of 9
