Home / 510(k) Clearances / K223084

510(k) K223084

MilkMate Breast Pump by Milkmate Products, Inc. — Product Code HGX

K223084 is an FDA 510(k) premarket notification submitted by Milkmate Products, Inc. for the device "MilkMate Breast Pump". The FDA issued a decision of Substantially Equivalent on March 16, 2023. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Milkmate Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2023
Date Received
September 30, 2022
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 Milkmate Products, Inc.

  • K241705 — MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm bre (July 12, 2024)

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