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510(k) K952034

MEDELA'S FOOT PUMP by Medela, Inc. — Product Code HGY

K952034 is an FDA 510(k) premarket notification submitted by Medela, Inc. for the device "MEDELA'S FOOT PUMP". The FDA issued a decision of Substantially Equivalent on September 12, 1995. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Medela, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type

Other clearances by Medela, Inc.

  • 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)
  • K191653 — Freestyle Flex (October 17, 2019)

Other clearances for product code HGY

  • K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (November 5, 2010)
  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (April 5, 2004)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)
  • K011519 — AMEDA HYGIENIKIT (August 15, 2001)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)
  • K962828 — EVERT-IT (February 10, 1997)
  • K952035 — NIPLETTE (July 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (December 10, 1993)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (September 26, 1990)

FDA data resources