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510(k) K252420

Wearable Breast Pump (Model W12) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
August 1, 2025
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.

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  • 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)
  • K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow) (May 30, 2025)
  • K250368 — Wearable Breast Pump (Model S21) (May 30, 2025)
  • K243508 — Wearable breast pump (model S12A) (April 21, 2025)
  • K250829 — Lacevo Wearable Breast Pump (Model S70) (April 17, 2025)
  • K250152 — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (April 2, 2025)

Other clearances for product code HGX

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  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
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  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
  • K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (December 19, 2025)
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