Cleared Traditional

K951325 - COMFEEL PLUS PRESSURE RELIEF DRESSING

K951325 is an FDA 510(k) clearance for COMFEEL PLUS PRESSURE RELIEF DRESSING, manufactured by Richard Hamer Assoc., Inc.. The device is a Class 1 General Hospital device with product code FMP cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K951325 · Richard Hamer Assoc., Inc. · General Hospital
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Jul 1995
Decision
130d
Days
Class 1
Risk

K951325 is an FDA 510(k) clearance for the COMFEEL PLUS PRESSURE RELIEF DRESSING. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Richard Hamer Assoc., Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6450 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Hamer Assoc., Inc. devices

FDA 510(k) Submission Details - K951325

510(k) Number K951325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1995
Decision Date July 31, 1995
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

FMP Device Classification - Class 1, General Controls

Product Code FMP Protector, Skin Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMP Protector, Skin Pressure

All 7
Devices cleared under the same product code (FMP) and FDA review panel - the closest regulatory comparables to K951325.
MEDSURG STERILE IMAGING PRODUCTS
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HEEL OR ELBOW PROTECTOR
K812344 · Fred Sammons, Inc. · Sep 1981
SPAN AIDS KIT
K792297 · American Hospital Supply Corp. · Dec 1979
HEEL OR ELBOW PROTECTOR
K772419 · Fred Sammons, Inc. · Jan 1978
SPECIALIST ARM & LEG PROTECTOR
K771519 · Johnson & Johnson Professionals, Inc. · Aug 1977