510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954857Substantially Equivalent for Some Indications

Comfeel:alginate Filler

MEDLINE INDUSTRIES, LP - Northfield, Fort Worth TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K954857 is the FDA 510(k) clearance record for COMFEEL:ALGINATE FILLER, a class I device, cleared for Coloplast Corp. on under FDA product code KMF (Bandage, Liquid). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K954857.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Coloplast Corp. 100 E. 15th St.,Suite 320, Fort Worth TX
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

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