Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
FDA 510(k) K260538 · Shenzhen Root Innovation Technology Co., Ltd.
510(k) numberK260538
Submission
- Device name
- Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd.
Shenzhen, CN - Received
- February 17, 2026
- Decision date
- June 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGX – Pump, Breast, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K261199 | Wearable Breast Pump (Model S32A)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/13/2026SE |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional | Shenzhen Changkun Technology Co., Ltd. | 06/26/2026SE |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional | Shenzhen Qinyi Electronic Technology Co., Ltd. | 06/25/2026SE |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/18/2026SE |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129…HGX · Traditional | Polybell (Guangzhou) Limited | 06/12/2026SE |
More from Polybell (Guangzhou) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | 06/18/2026SE |
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | 05/15/2026SE |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)HGX · Traditional | 04/29/2026SE |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A…HGX · Traditional | 04/08/2026SE |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A…HGX · Traditional | 04/07/2026SE |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)HGX · Traditional | 03/09/2026SE |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-…HGX · Special | 10/29/2025SE |
| K251394 | Momcozy Wearable Breast Pump (BP223)HGX · Traditional | 09/08/2025SE |
| K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy…HGX · Special | 12/20/2024SE |
Questions and answers
When was Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) cleared by the FDA?
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (K260538) received a 510(k) decision of Substantially Equivalent on June 17, 2026, 120 days after the submission was received.
What is the product code of K260538?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.