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)— 510(k) K254258
Substantially EquivalentShenzhen Root Innovation Technology Co., Ltd.
FDA 510(k) clearance K254258 for 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), Substantially Equivalent on 2026-04-08. Applicant: Shenzhen Root Innovation Technology Co., Ltd.. Device class: 2.
Summary
This filing covers 12 models of the Momcozy wearable breast pump across the BP137 and BP141 families. Momcozy sells mostly direct to consumers online. Product code HGX covers powered breast pumps.
Class II, 21 CFR 884.5160. The Obstetrics and Gynecology panel reviewed it as a Traditional 510(k).
Shenzhen Root Innovation Technology filed from Shenzhen, China. Review took 100 days (December 29, 2025 to April 8, 2026), quick for a 12-model submission.
Clearance details
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code HGX
view all- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- K260643 — Cimilre Dual Max
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
More clearances from Shenzhen Root Innovation Technology Co., Ltd.
view all- K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
- K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
- K253629 — Momcozy Nasal Aspirator (BN007)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
Adverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.