Home / 510(k) Clearances / K253149

510(k) K253149

Motion InBra (YM-8801) wearable breast pump by Medela, LLC — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
September 25, 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 Medela, LLC

  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K251377 — Magic InBra (September 18, 2025)
  • K232608 — Duo Hands-free Breast Pump (April 12, 2024)
  • K223388 — Invia® Integrated Dressing (July 7, 2023)
  • K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System (July 26, 2022)
  • K210759 — Solo, Swing Maxi (August 11, 2021)
  • K200508 — Pump In Style (June 15, 2020)
  • K191653 — Freestyle Flex (October 17, 2019)
  • K182191 — Invia Abdominal Dressing Kit (February 1, 2019)
  • K180415 — Invia White Foam NPWT (November 2, 2018)

Other clearances for product code HGX

  • 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)
  • K252420 — Wearable Breast Pump (Model W12) (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)