510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081463Substantially Equivalent

Mebby Gentlefeed Duo Breast Pump/dual Expresser Pump

Medel S.p.A., Cary NC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K081463 is the FDA 510(k) clearance record for MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP, a class II device, cleared for Medel S.P.A. on under FDA product code HGX (Pump, Breast, Powered). FDA records list 4 510(k) clearances for Medel S.P.A., from to . As of , FDA records show no recalls naming K081463.

Clearance record

Decision date
Received
(259 days to decision)
Product code
HGX Pump, Breast, Powered
Regulation
21 CFR 884.5160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medel S.P.A. 112 Cavistion Way, Cary NC
510(k) summary
Statement
Third party review
No

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