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510(k) K261199

Wearable Breast Pump (Model S32A) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

K261199 is an FDA 510(k) premarket notification submitted by Shenzhen TPH Technology Co., Ltd. for the device "Wearable Breast Pump (Model S32A)". The FDA issued a decision of Substantially Equivalent on July 13, 2026. 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 13, 2026
Date Received
April 13, 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 by Shenzhen TPH Technology Co., Ltd.

  • 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)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K251754 — Wearable Breast Pump (Model S33) (September 8, 2025)
  • K250383 — Wearable Breast Pump (Model W6) (August 20, 2025)
  • K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (July 31, 2025)
  • K250350 — Thrive 2-in-1 Breast Pump (Model P3) (July 15, 2025)
  • K250368 — Wearable Breast Pump (Model S21) (May 30, 2025)

Other clearances for product code HGX

  • 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)
  • 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)

FDA data resources