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, BP334-A, BP334-B, BP334-C, BP334-D, BP434)

K-Number: K253914 · 2026-04-29

ApplicantShenzhen Root Innovation Technology Co., Ltd.
Decision Date2026-04-29
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is a medical device manufactured by Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under approval number K253914. 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, BP334-A, BP334-B, BP334-C, BP334-D, BP434)?

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253914.

When was Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) approved by the FDA?

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) received FDA 510(k) clearance on 2026-04-29, under approval number K253914.

What company makes Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)?

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is manufactured by Shenzhen Root Innovation Technology Co., Ltd..

What is the FDA product code for Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)?

The FDA product code for Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is HGX.

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

K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

Related Devices (Code: HGX)

K254125Electric Breast Pump (HL-3058 II Pro)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

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.

↑