FDA 510(k)

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

K-Number: K254254 · 2026-06-18

ApplicantShenzhen Root Innovation Technology Co., Ltd.

Decision Date2026-06-18

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K254254. 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 (BP311, BP311-A, BP311-B, BP311-C, BP311-D)?

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K254254.

When did Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) receive FDA 510(k) clearance?

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K254254.

Who is the listed applicant for Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)?

The FDA 510(k) record lists Shenzhen Root Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)?

The FDA product code for Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) is HGX.

Other records listing Shenzhen Root Innovation Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )K253629Momcozy Nasal Aspirator (BN007)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)K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)

View all 13 devices →

Related Devices (Code: HGX)

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)Polybell (Guangzhou) Limited

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.