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510(k) K250843

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

K250843 is an FDA 510(k) premarket notification submitted by Shenzhen TPH Technology Co., Ltd. for the device "Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Shenzhen TPH Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2025
Date Received
March 20, 2025
Clearance Type
Special
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 by Shenzhen TPH Technology Co., Ltd.

  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (June 9, 2026)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)
  • K260033 — Wearable Breast Pump (Model S21A) (April 8, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K251754 — Wearable Breast Pump (Model S33) (September 8, 2025)
  • K250383 — Wearable Breast Pump (Model W6) (August 20, 2025)
  • K250350 — Thrive 2-in-1 Breast Pump (Model P3) (July 15, 2025)

Other clearances for product code HGX

  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 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)

FDA data resources