Cleared Traditional

COMFEEL PLUS PRESSURE RELIEF DRESSING (K951325) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

Device Classification

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.