Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

K-Number: K253283 · 2025-10-29

ApplicantShenzhen Root Innovation Technology Co., Ltd.
Decision Date2025-10-29
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is a medical device manufactured by Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-29 under approval number K253283. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)?

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253283.

When was Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) approved by the FDA?

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) received FDA 510(k) clearance on 2025-10-29, under approval number K253283.

What company makes Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)?

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is manufactured by Shenzhen Root Innovation Technology Co., Ltd..

What is the FDA product code for Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)?

The FDA product code for Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is HGX.

Related Clinical Trials

NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07277738 Precision Supplemental Imaging in Women With Dense Breasts NOT_YET_RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT06865755 Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41779786 Stress-dependent growth in breast cancer arises from a mechano-osmotic coupling and cell-sizing checkpoint. Proceedings of the National Academy of Sciences of the United States of America (2026)

Other Devices by Shenzhen Root Innovation Technology Co., Ltd.

K241680Momcozy Wearable Breast Pump (BP311) K233880Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) K251394Momcozy Wearable Breast Pump (BP223) K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) K254258Momcozy 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)

View all 9 devices →

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑