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510(k) K254300

eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) by Anker Innovations Limited — Product Code HGX

K254300 is an FDA 510(k) premarket notification submitted by Anker Innovations Limited for the device "eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)". The FDA issued a decision of Substantially Equivalent on May 29, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Anker Innovations Limited has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
December 31, 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 Anker Innovations Limited

  • K250207 — eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (August 11, 2025)

Other clearances for product code HGX

  • 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)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)

FDA data resources