Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
Device Facts
| Record ID | K262774 |
|---|---|
| Device Name | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) |
| Applicant | Guangdong Horigen Mother & Baby Products Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Sep 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Indications for Use
The Wearable Breast Pump (Model: XN/MD-2249BS and ZFHF) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
Device Story
Wearable, single-user powered breast pump; home-use. Device consists of pump unit, silicone flange, diaphragm, valve, linker, and milk collection bottle. Operates by creating a seal around the nipple via silicone flange; applies/releases suction to express milk. Backflow protection mechanism prevents milk from entering vacuum system. User interface includes four buttons for power, mode selection (stimulation/expression), and vacuum level adjustment; LED display provides status. Powered by internal rechargeable Lithium-ion battery; charged via external USB adapter (DC 5V, 1A). Device does not function while charging. Embedded software controls vacuum cycles and levels. Stimulation mode: 5 levels; Expression mode: 9 levels. Vacuum range: -30 to -240 mmHg depending on model/mode. Cycle speeds: 26-100 cycles/min. Benefits include portable, hands-free milk expression for lactating women.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10, -23), electrical safety (ANSI/AAMI ES60601-1, IEC 60601-1-11), battery safety (IEC 62133-2), electromagnetic compatibility (IEC 60601-1-2), and performance verification (vacuum levels, backflow protection, use life, battery functionality).
Technological Characteristics
Powered breast pump; wearable form factor. Materials: milk-contacting parts compliant with 21 CFR 177. Energy: internal Li-ion battery, USB-rechargeable. Sensing/Actuation: microcontroller-based vacuum pump. Connectivity: none. Sterilization: non-sterile. Software: embedded, basic documentation level. Vacuum: -30 to -240 mmHg. Cycle speed: 26-100 cycles/min.
Indications for Use
Indicated for lactating women to express and collect milk from their breasts. 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 (Model: W12) (K252420)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
September 1, 2026
Guangdong Horigen Mother & Baby Products Co., Ltd.
% Prithul Bom
Most Responsible Person
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul, Minnesota 55114
Re: K262774
Trade/Device Name: Wearable Breast Pump
(Model: XN/MD-2249BS, ZFHF)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered breast pump
Regulatory Class: II
Product Code: HGX
Dated: August 4, 2026
Received: August 4, 2026
Dear Prithul Bom:
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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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
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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
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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)
K262774
Device Name
Wearable Breast Pump (Model: XN/MD-2249BS, ZFHF)
Indications for Use (Describe)
The Wearable Breast Pump (Model: XN/MD-2249BS and ZFHF) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It 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)
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PSC Publishing Services (301) 443-6740 EF
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# 510(k) Summary – K262774
## 1. Information of Submitter and Correspondent
### Submitter’s information:
**Company Name:** Guangdong Horigen Mother & Baby Products Co., Ltd.
**Street Address:** No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District
**City:** Shantou
**State/ Province:** Guangdong
**Country:** China
**Contact Person:** Changxin Chen
**Occupation Title:** General Manager Assistant
**Telephone:** 86-754-83613668
**Date Prepared:** September 1, 2026
## 2. Device Information
| Device name: | Wearable Breast Pump (Model: XN/MD-2249BS, ZFHF) |
| --- | --- |
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Product code : | HGX (Pump, Breast, Powered) |
| Device Class: | Class II |
## 3. Predicate Device
| **Manufacturer** | Shenzhen TPH Technology Co., Ltd. |
| --- | --- |
| **Legally Marketed Device** | Wearable Breast Pump (Model: W12) |
| **510(K) Number** | K252420 |
The predicate device has not been subject to a design-related recall.
## 4. Device Description
The Wearable Breast Pump (Model: XN/MD-2249BS and ZFHF) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Wearable Breast Pump is to be used in a home environment. The device is provided non-sterile and can be used on one breast (single pumping). The device is an integrated wearable design, consisting of a pump main unit, a silicone flange, a diaphragm, a valve, a linker, a milk bottle and a bottle lid. All parts that come into contact with milk are made of materials that comply with 21 CFR 177.
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The device has four buttons allowing the user to power the device on/off and select between two pumping modes (expression and stimulation). Stimulation mode consist of 5 vacuum levels and expression mode consists of 9 vacuum levels. The Wearable Breast Pump (Model: XN/MD-2249BS and ZFHF) is capable of providing vacuum levels from -30 to -120 mmHg with cycle speed 100 cycles/min in stimulation mode, vacuum levels from -30 to -240 mmHg with cycle speed from 35-90 cycles/minute in expression mode of XN/MD-2249BS, vacuum levels from -120 to -240 mmHg with cycle speed from 26-60 cycles/minute in expression mode of ZFHF.
The pump operates on an internal rechargeable Lithium-ion battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter (DC 5V, 1A). The pump main unit operates on embedded software. Software updates by end-users are not supported. The Wearable Breast Pump expresses by creating a seal around the nipple using the silicone flange and applying and releasing suction to the nipple. The milk is collected in a milk collection bottle. To prevent milk from flowing into the vacuum, a backflow protection mechanism physically separates the milk-contacting pathway from the vacuum system.
### 5. Indications for Use
The Wearable Breast Pump (Model: XN/MD-2249BS and ZFHF) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
### 6. Comparison of Intended Use/Indications for Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Device | Subject device Wearable breast pump (Model: XN/MD-2249BS and ZFHF) | Predicate device Wearable Breast Pump (Model: W12) (K252420) | Comparison |
| --- | --- | --- | --- |
| Manufacturer | Guangdong Horigen Mother & Baby Products Co., Ltd. | Shenzhen TPH Technology Co., Ltd. | NA |
| Classification | Class II Device, HGX (21CFR 884.5160) | Class II Device, HGX (21 CFR884.5160) | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Indications for Use (IFU)/intended use | The Wearable Breast Pump (model: XN/MD-2249BS and ZFHF) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user. | The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user. | Same |
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| Device | Subject device Wearable breast pump (Model: XN/MD-2249BS and ZFHF) | Predicate device Wearable Breast Pump (Model: W12) (K252420) | Comparison |
| --- | --- | --- | --- |
| OTC or Rx | OTC | OTC | Same |
| Pump Options | Single | Single | Same |
| Cycling control | Microcontroller | Microcontroller | Same |
| Backflow Protection | Yes | Yes | Same |
| Suction Modes | Stimulation Mode, Expression Mode | Stimulation Mode, Expression Mode, Auto Mode, Massage Mode, Hot Compress Mode | Different – the predicate device includes additional modes (Auto Mode, Massage Mode, Hot Compress Mode) that are not present on the subject devices. Lack of these features on the subject devices do not raise different questions of safety and effectiveness to the predicate device. |
| Suction levels | Stimulation mode: 5 levels Expression mode: 9 levels | 12 | Different – the suction levels for the stimulation and expression modes that are present on both the subject and predicate devices are not identical. These differences do not raise different questions of safety and effectiveness to the predicate device. |
| Adjustable suction levels | Yes | Yes | Same |
| Vacuum range | **XN/MD-2249BS:** Stimulation mode: -30 to -120 (±7.5) mmHg Expression mode: -30 to -240 (±7.5) mmHg **ZFHF:** Stimulation mode: -30 to -120 (±7.5) mmHg Expression mode: -120 to -240 (±7.5) mmHg | Stimulation mode: 40-150 mmHg Expression mode: 120-245 mmHg Massage mode: 40-120 mmHg Auto mode: 40-245 mmHg | Different – the vacuum ranges for the stimulation and expression modes that are present on both the subject and predicate devices are not identical. These differences do not raise different questions of safety and effectiveness to the predicate device. |
| Cycle Speed | **XN/MD-2249BS:** Stimulation mode: 100 (±2) cycles/min Expression mode: 35 to 90 (±2) cycles/min **ZFHF:** Stimulation mode: 100 (±2) cycles/min Expression mode: 26 to 60 (±2) cycles/min | Stimulation mode: 86 to 127 cpm Expression mode: 34 to 109 cpm Massage mode: 90 to 143 cpm Auto mode: 34 to 130 cpm | Different – the cycle speeds for the stimulation and expression modes that are present on both the subject and predicate devices are not identical. These differences do not raise different questions of safety and effectiveness to the predicate device. |
| Controls | ON/OFF button; Mode switch button; Vacuum up/Vacuum down vacuum button; LED display | On-Off switch, mode selection/long press, vacuum adjustment, LED display, heat compress button | Different – there are differences in the controls of the subject and predicate devices. These differences do not raise different questions of safety and effectiveness to the predicate device. |
| Power Supply | Li-Ion Battery | Li-Ion Battery | Same |
| Indicators | Yes, LED | Yes, LED | Same |
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| Device | Subject deviceWearable breast pump (Model: XN/MD-2249BS and ZFHF) | Predicate deviceWearable Breast Pump (Model: W12) (K252420) | Comparison |
| --- | --- | --- | --- |
| Design | Wearable pump with combined Milk Collector and Flange | Wearable pump with combined Milk Collector and Flange | 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 subject and predicate device have similar technological features, including wearable operation, power supply, and user interface. However, as shown in the table above, there are technological differences between the subject and predicate device, including additional operational modes for the predicate device, different vacuum and cycle specifications, and device controls. The different technological characteristics of the subject devices, as compared to the predicate device, do not raise different questions of safety and effectiveness.
## 7. Summary of Non-Clinical Testing:
### 7.1 Biocompatibility
The biocompatibility evaluation for the patient-contacting components was conducted in accordance with the 2023 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””, as follows:
• ISO 10993-5:2009, Biological evaluation of medical devices–Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2021, Biological evaluation of medical devices –Part 10: Tests for skin sensitization
• ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
### 7.2 Electrical Safety
Testing was conducted in accordance with and found to comply with the following standards:
- ANSI/AAMI ES60601-1:2005+AMD1:2012+AMD2:2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,
- IEC 62133-2:2017+AMD1:2021, 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 60601-1-11:2015+AMD1:2020 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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### **7.3 Electromagnetic Compatibility**
Testing was conducted in accordance with the FDA Guidance “Electromagnetic Compatibility (EMC) of Medical Devices,” issued June 6, 2022 and IEC 60601-1-2:2020 Medical Electrical Equipment - Part 1-2: “General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.”
### **7.4 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.”
### **7.5 Performance Testing**
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests included:
- 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 device
- 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.
## **8. Conclusions**
The results of the performance testing described above demonstrate that the Wearable breast pump (Model: XN/MD-2249BS and ZFHF) is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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