510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031614Substantially Equivalent

Medela Pump in Style Advanced Breast Pump

Medela AG, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031614 is the FDA 510(k) clearance record for MEDELA PUMP IN STYLE ADVANCED BREAST PUMP, a class II device, cleared for Medela, Inc. on under FDA product code HGX (Pump, Breast, Powered). FDA records list 56 510(k) clearances for Medela, Inc., from to . As of , FDA records show one recall naming K031614.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HGX Pump, Breast, Powered
Regulation
21 CFR 884.5160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medela, Inc. 1101 Corporate Dr., Mchenry IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HGX

Trailing 12 months
37 clearances under product code HGX in the twelve months to October 2026, April 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code HGX, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20262
April 20268
May 20263
June 20268
July 20262
August 20262
September 20263
October 20260