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510(k) K250383

Wearable Breast Pump (Model W6) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

K250383 is an FDA 510(k) premarket notification submitted by Shenzhen TPH Technology Co., Ltd. for the device "Wearable Breast Pump (Model W6)". The FDA issued a decision of Substantially Equivalent on Aug 20, 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 23 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 20, 2025
Date Received
Feb 11, 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
510(k)

Other clearances by Shenzhen TPH Technology Co., Ltd.

  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (Jun 9, 2026)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)
  • K260033 — Wearable Breast Pump (Model S21A) (Apr 8, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (Feb 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (Feb 13, 2026)
  • K251754 — Wearable Breast Pump (Model S33) (Sep 8, 2025)
  • K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (Jul 31, 2025)

Other clearances for product code HGX

  • K261782 — MODO DUO Electric Pump (B11621, B11673) (Oct 16, 2026)
  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)

FDA data resources

Source: FDA 510(k) database entry for K250383. Report a data issue: hello@regdatalab.com.