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

FDA 510(k)

Wearable breast pump (QY-101, QY-102, QY-108)

K-Number: K261025 · 2026-06-25

ApplicantShenzhen Qinyi Electronic Technology Co., Ltd.
Decision Date2026-06-25
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable breast pump (QY-101, QY-102, QY-108) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Qinyi Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K261025. 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 Wearable breast pump (QY-101, QY-102, QY-108)?

Wearable breast pump (QY-101, QY-102, QY-108) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Shenzhen Qinyi Electronic Technology Co., Ltd.. The 510(k) number is K261025.

When did Wearable breast pump (QY-101, QY-102, QY-108) receive FDA 510(k) clearance?

Wearable breast pump (QY-101, QY-102, QY-108) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K261025.

Who is the listed applicant for Wearable breast pump (QY-101, QY-102, QY-108)?

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

What is the FDA product code for Wearable breast pump (QY-101, QY-102, QY-108)?

The FDA product code for Wearable breast pump (QY-101, QY-102, QY-108) is HGX.

Related Devices (Code: HGX)

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.

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.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation 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.

↑