Cleared Traditional

PAD, POLYETHER FOAM, OPEN CELL (K760315) - FDA 510(k) Clearance

Class I General Hospital device.

K760315 · Gaymar Industries, Inc. · General Hospital
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Aug 1976
Decision
16d
Days
Class 1
Risk

K760315 is an FDA 510(k) clearance for the PAD, POLYETHER FOAM, OPEN CELL. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Gaymar Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1976 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gaymar Industries, Inc. devices

Submission Details

510(k) Number K760315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1976
Decision Date August 11, 1976
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
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.