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510(k) K191653

Freestyle Flex by Medela AG — Product Code HGX

K191653 is an FDA 510(k) premarket notification submitted by Medela AG for the device "Freestyle Flex". The FDA issued a decision of Substantially Equivalent on October 17, 2019. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Medela AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2019
Date Received
June 20, 2019
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 AG

  • K253510 — Freestyle Mini Hands-free (April 10, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • 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)
  • K182191 — Invia Abdominal Dressing Kit (February 1, 2019)

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)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)

FDA data resources