510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951325Substantially Equivalent

Comfeel Plus Pressure Relief Dressing

Richard Hamer Assoc., Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951325 is the FDA 510(k) clearance record for COMFEEL PLUS PRESSURE RELIEF DRESSING, a class I device, cleared for Richard Hamer Assoc., Inc. on under FDA product code FMP (Protector, Skin Pressure). FDA records list 8 510(k) clearances for Richard Hamer Assoc., Inc., from to . As of , FDA records show no recalls naming K951325.

Clearance record

Decision date
Received
(130 days to decision)
Product code
FMP Protector, Skin Pressure
Regulation
21 CFR 880.6450
Device class
Class I
Review panel
General Hospital
Applicant
Richard Hamer Assoc., Inc. P.O. Box 16598, Fort Worth TX
510(k) summary
Statement
Third party review
No

Clearances, product code FMP

Trailing 12 months

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

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