Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)

K254258 · Shenzhen Root Innovation Technology Co., Ltd. · HGX · Apr 8, 2026 · Obstetrics/Gynecology

Device Facts

• Record ID: K254258
• Device Name: Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
• Applicant: Shenzhen Root Innovation Technology Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Apr 8, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications for Use

The Momcozy Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Device Story

Wearable powered breast pump; single-user; home environment. Device uses diaphragm-type vacuum pump driven by microprocessor to create seal around nipple via flange. User selects stimulation, expression, or mixed modes via buttons/LED interface; controls vacuum levels and cycling rates. Milk collected in integrated container; backflow protection membrane prevents fluid ingress into vacuum system. Powered by internal rechargeable lithium-ion polymer battery. Device assists lactating women with milk expression; output is collected milk for storage.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, -10, -23), electrical safety (ANSI/AAMI ES60601-1, IEC 62133-2, IEC 60601-1-11), EMC (IEC 60601-1-2), and performance verification (vacuum levels, backflow protection, use life, battery performance).

Technological Characteristics

Powered breast pump; diaphragm-type vacuum pump. Materials: milk-contacting components compliant with 21 CFR 177. Power: internal rechargeable lithium-ion polymer battery (3.7V). Interface: LED display, buttons. Connectivity: none. Sterilization: non-sterile. Software: embedded control program (Basic Documentation level).

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 (Model LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (K241322)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

April 8, 2026

Shenzhen Root Innovation Technology Co., Ltd.
Caitlin Liang
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd.
Bantian St., Longgang
Shenzhen, 518129
CHINA

Re: K254258
Trade/Device Name: Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: December 29, 2025
Received: December 29, 2025

Dear Caitlin Liang:

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}

K254258 - Caitlin Liang
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

{2}

K254258 - Caitlin Liang
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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, PhD
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}

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) K254258 | |
| Device Name Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | |
| Indications for Use (Describe) The Momcozy Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to 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 [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." | |

{4}

K254258
Page 1 of 5

510(k) Summary – K254258

1. Submitter Information
Applicant: Shenzhen Root Innovation Technology Co., Ltd.
Address: #2-201, Floor 2 Hasee Computer Building, No. 2 Beier Rd, Bantian Street, Longgang, Shenzhen, 518129, China
Tel.: [phone]

2. Correspondent Information
Contact: Ms. Caitlin Liang
Shenzhen Root Innovation Technology Co., Ltd.
Email: [e-mail]

3. Date prepared: April 8, 2026

4. Device Information
Device Name: Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
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: Electric Breast Pump (Model LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
510(k) Number: K241322
Manufacturer: JOYTECH Healthcare Co., Ltd.

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

6. Device Description

The Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) 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. The devices are powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: pump motor (main unit), milk collection set (flange, diaphragm, silicone valve, milk collector, flange cover) and accessories (flange insert, charging cable). The device uses a diaphragm-type vacuum pump driven by a microprocessor. The user interface consists of buttons and LED display and allows the user to switch from stimulation, expression, and mixed modes and control the vacuum levels within those modes.

For the BP137 models, all available modes consist of 15 vacuum levels. For the BP141, all available modes consist of 9 vacuum levels. The BP137 series is capable of providing vacuum levels from 80-185 mmHg with cycling rates from 48-98 cycles per minute in stimulation mode, vacuum levels from 115-290 mmHg with

{5}

K254258
Page 2 of 5

cycling rates from 20-67 cycles per minute in expression mode, and vacuum levels from 80-290 mmHg with cycling rates from 39-83 cycles per minute in mixed mode. The BP141 series is capable of providing vacuum levels from 85-140 mmHg with cycling rates from 56-94 cycles per minute in stimulation mode, vacuum levels from 135-290 mmHg with cycling rates from 25-54 cycles per minute in expression mode, and vacuum levels from 85-290 mmHg with cycling rates from 46-65 cycles per minute in mixed mode. The devices are charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device is not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

## 7. Indications for Use

The Momcozy Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

## 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

| | Momcozy Wearable Breast Pump ((BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)) K254258 Subject Device | Electric Breast Pump (Model LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) K241322 Predicate Device | Comparison |
| --- | --- | --- | --- |
| Product Code | HGX | HGX | Same |
| Indications for Use | The Momcozy Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | The Electric Breast Pump (Model LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user. | Similar |
| Single User | Yes | Yes | Same |
| Single/double pump | Single or double | Single or double | Same |

{6}

K254258
Page 3 of 5

| Media separation (backflow protection) | Yes | Yes | Same |
| --- | --- | --- | --- |
| Cycling control mechanism | Microcontroller | Microcontroller | Same |
| Expression pattern | 2-Phase | 2-Phase | Same |
| Power supply | BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B:
DC 3.7V/2300mAh Rechargeable lithium battery

BP141, BP141-A, BP141-B, BP141-C, BP141-D:
DC 3.7 V / 1800mAh Rechargeable lithium battery | LD-3010L,LD-2010L:
In:100 - 240 VAC 50/60 Hz 0.25A
Mains Out: 5VDC, 1.0A
Batt Out: 3.7VDC 2000mAh
LD-3010,LD-2010:
In:100 – 240 VAC 50/60 Hz 0.25A
Mains Out: 5VDC, 1.0A
Batt Out: 4 AA batteries | Different |
| Suction levels (mmHg) | BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B:
Expression: 115 to 290 (±20)
Stimulation: 80 to 185 (±20)
Mixed: 80 to 290 (±20)

BP141, BP141-A, BP141-B, BP141-C, BP141-D:
Expression: 135 to 290 (±20)
Stimulation: 85 to 140 (±20)
Mixed: 85 to 290 (±20) | Expression: 50-290 ± 30
Stimulation: 40-100 ± 30 | Different |
| Cycles per minute | BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B:
Expression: 20 to 67 (±5)
Stimulation: 48 to 98 (±5)
Mixed: 39 to 83 (±5)

BP141, BP141-A,
BP141-B, BP141-C, BP141-D:
Expression: 25 to 54 (±5)
Stimulation: 56 to 94 (±5)
Mixed: 46-65 (±5) | Expression: 20 to 65 (± 5)
Stimulation: 80 to 120 (±5) | Different |
| Suction levels | BP137 series – 15 levels stimulation, expression, mixed
BP141 series – 9 levels stimulation, expression, mixed | 9 expression, bionic, variable frequency, 6 stimulation | Different |
| Available modes | Stimulation, expression, mixed | Stimulate mode,Expression mode, Bionic sucking mode,Variable frequency pumping mode | Different |
| User Interface | On-Off switch, mode change button, vacuum adjustment buttons, LED | On-Off switch, mode change button, vacuum adjustment buttons, LED | Same |
| Adjustable Suction Levels | Yes | Yes | Same |

{7}

K254258
Page 4 of 5

| Mobile Application | No | No | Same |
| --- | --- | --- | --- |
| Design | Wearable | LD-3010L, LD-3010, LD-2010L, LD-2010: Tabletop
LD-208L: Wearable | Same |

The indications for use of the subject and predicate devices are nearly 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 wearable operation, 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 power supply. 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

Biocompatibility testing was conducted on the flange portion of the device. 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.” The following tests were conducted on the leveraged device:

- Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-23:2021)
- 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 the following standards:

- 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.

### Electromagnetic Compatibility

Testing was conducted in accordance with the FDA Guidance “Electromagnetic Compatibility (EMC) of Medical Devices,” issued June 6, 2022 and IEC 60601-1-2:2014 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.”

{8}

K254258
Page 5 of 5

## 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.
- 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 the The Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) is as safe and effective as the predicate device and support a determination of substantial equivalence.