510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982234Substantially Equivalent

Al-Gen Calcium Alginate Dressing

Innovative Technologies, Ltd., Winsford, Cheshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982234 is the FDA 510(k) clearance record for AL-GEN CALCIUM ALGINATE DRESSING, a class I device, cleared for Innovative Technologies , Ltd. on under FDA product code KMF (Bandage, Liquid). FDA records list 14 510(k) clearances for Innovative Technologies , Ltd., from to . As of , FDA records show no recalls naming K982234.

Clearance record

Decision date
Received
(75 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Innovative Technologies , Ltd. Rd. Three, Winsford, Cheshire, GB
510(k) summary
Summary
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