510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K980863Substantially Equivalent

Dumex Pak-Its Non-Woven Dressing Impregnated Sith Sodium Chloride (Hypertonic)

Dumex Medical Surgical Products, Ltd., Toronto, Orntario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980863 is the FDA 510(k) clearance record for DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC), a class I device, cleared for Dumex Medical Surgical Products, Ltd. on under FDA product code KMF (Bandage, Liquid). FDA records list 13 510(k) clearances for Dumex Medical Surgical Products, Ltd., from to . As of , FDA records show no recalls naming K980863.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Dumex Medical Surgical Products, Ltd. 104 Shorting Rd., Toronto, Orntario, CA
510(k) summary
Statement
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMF, 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