510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941216Substantially Equivalent for Some Indications

Hydroderm Extra Thin Intelligent Hydrocollioid Dressing

Wilshire Medical Products, Dallas TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K941216 is the FDA 510(k) clearance record for HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING, a class I device, cleared for Wilshire Medical Products on under FDA product code KMF (Bandage, Liquid). FDA records list 12 510(k) clearances for Wilshire Medical Products, from to . As of , FDA records show no recalls naming K941216.

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
Wilshire Medical Products 11420 Mathis Ave., Dallas 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 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