Home / 510(k) Clearances / K250152

510(k) K250152

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2025
Date Received
January 21, 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.

  • 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)
  • K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow) (May 30, 2025)
  • K243508 — Wearable breast pump (model S12A) (April 21, 2025)
  • K250829 — Lacevo Wearable Breast Pump (Model S70) (April 17, 2025)

Other clearances for product code HGX

  • K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (March 12, 2026)
  • K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, (March 9, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
  • 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)