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510(k) K254258

Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) by Shenzhen Root Innovation Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 8, 2026
Date Received: December 29, 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.

K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 (April 7, 2026)
K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, (March 9, 2026)
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

K253510 — Freestyle Mini Hands-free (April 10, 2026)
K260033 — Wearable Breast Pump (Model S21A) (April 8, 2026)
K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 (April 7, 2026)
K250208 — SPECTRA Wearable 2 (April 6, 2026)
K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (April 3, 2026)
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)
K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)