Wearable breast pump (QY-101, QY-102, QY-108)— 510(k) K261025

Name: FDA 510(k) clearance K261025
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Shenzhen Qinyi Electronic Technology Co., Ltd.

FDA 510(k) clearance K261025 for Wearable breast pump (QY-101, QY-102, QY-108), Substantially Equivalent on 2026-06-25. Applicant: Shenzhen Qinyi Electronic Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Qinyi Electronic Technology Co., Ltd.
Product code: Code HGX
Device class: Class 2
Regulation: 21 CFR 884.5160
Advisory panel: Obstetrics/Gynecology
Date received: 2026-03-30
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGX

view all

K260643 — Cimilre Dual Max2026-08-21
K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))2026-08-20
K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)2026-07-24
K261199 — Wearable Breast Pump (Model S32A)2026-07-13
K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)2026-06-26

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.