510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952034Substantially Equivalent

Medela's Foot Pump

Medela AG, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952034 is the FDA 510(k) clearance record for MEDELA'S FOOT PUMP, a class I device, cleared for Medela, Inc. on under FDA product code HGY (Pump, Breast, Non-Powered). FDA records list 56 510(k) clearances for Medela, Inc., from to . As of , FDA records show no recalls naming K952034.

Clearance record

Decision date
Received
(134 days to decision)
Product code
HGY Pump, Breast, Non-Powered
Regulation
21 CFR 884.5150
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Medela, Inc. 4610 Prime Pkwy., Mchenry IL
510(k) summary
Statement
Third party review
No

Clearances, product code HGY

Trailing 12 months

FDA records hold no clearances under product code HGY in the trailing twelve months.

FDA records show no clearances under product code HGY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260