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510(k) K261025

Wearable breast pump (QY-101, QY-102, QY-108) by Shenzhen Qinyi Electronic Technology Co., Ltd. — Product Code HGX

K261025 is an FDA 510(k) premarket notification submitted by Shenzhen Qinyi Electronic Technology Co., Ltd. for the device "Wearable breast pump (QY-101, QY-102, QY-108)". The FDA issued a decision of Substantially Equivalent on June 25, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2026
Date Received
March 30, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances for product code HGX

  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 (June 12, 2026)
  • K250129 — AViTA Breast Pump (June 11, 2026)
  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (June 9, 2026)
  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)
  • K254125 — Electric Breast Pump (HL-3058 II Pro) (May 13, 2026)

FDA data resources