Cleared Traditional

K261025 - Wearable breast pump (QY-101, QY-102, QY-108)

K261025 is an FDA 510(k) clearance for Wearable breast pump (QY-101, manufactured by Shenzhen Qinyi Electronic Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K261025 · Shenzhen Qinyi Electronic Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
87d
Days
Class 2
Risk

K261025 is an FDA 510(k) clearance for the Wearable breast pump (QY-101, QY-102, QY-108). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Shenzhen Qinyi Electronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 25, 2026 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Qinyi Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K261025

510(k) Number K261025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2026
Decision Date June 25, 2026
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 161d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Huide Medical Technology Service Group Co., Ltd.
Amos Zou

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 228
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K261025.
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Wearable Breast Pump (Model S32A)
K261199 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
K250070 · Shenzhen Changkun Technology Co., Ltd. · Jun 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
K254254 · Shenzhen Root Innovation Technology Co., Ltd. · Jun 2026
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
K260538 · Shenzhen Root Innovation Technology Co., Ltd. · Jun 2026
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
K260346 · Polybell (Guangzhou) Limited · Jun 2026