510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894916Substantially Equivalent

Comfeel Transparent Dressing

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

K894916 is the FDA 510(k) clearance record for COMFEEL TRANSPARENT DRESSING, a class I device, cleared for Coloplast A/S on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K894916.

Clearance record

Decision date
Received
(55 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Coloplast A/S C/O Richard Hamer Assoc.Inc., Fort Woth TX
Third party review
No

Clearances, product code KGX

Trailing 12 months

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

FDA records show no clearances under product code KGX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGX, 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