Home / 510(k) Clearances / K253934

510(k) K253934

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) by Shenzhen Root Innovation Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2026
Date Received
December 9, 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 Root Innovation Technology Co., Ltd.

  • K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP4 (October 29, 2025)
  • K251394 — Momcozy Wearable Breast Pump (BP223) (September 8, 2025)
  • K241680 — Momcozy Wearable Breast Pump (BP311) (December 20, 2024)
  • K233880 — Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) (March 6, 2024)

Other clearances for product code HGX

  • K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (March 12, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (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)
  • 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)
  • K251932 — Spectra Platinum (November 25, 2025)