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
K904412Substantially Equivalent for Some Indications

Allevyn Dressing Claims Change

Smith & Nephew United, Inc., Largo FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K904412 is the FDA 510(k) clearance record for ALLEVYN DRESSING CLAIMS CHANGE, a class I device, cleared for Smith & Nephew United, Inc. on under FDA product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption). FDA records list 34 510(k) clearances for Smith & Nephew United, Inc., from to . As of , FDA records show no recalls naming K904412.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Regulation
21 CFR 878.4018
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Smith & Nephew United, Inc. 11775 Starkley Rd., Largo FL
Third party review
No

Clearances, product code KOZ

Trailing 12 months

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

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