Cleared Traditional

SOF. CARE CUSHION & SOF-CARE CUSHION COVER (K851027) - FDA 510(k) Clearance

Class I Physical Medicine device.

K851027 · Gaymar Industries, Inc. · Physical Medicine device
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Jun 1985
Decision
98d
Days
Class 1
Risk

K851027 is an FDA 510(k) clearance for the SOF. CARE CUSHION & SOF-CARE CUSHION COVER. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on June 18, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3175 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Gaymar Industries, Inc. devices

Submission Details

510(k) Number K851027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date June 18, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIC Cushion, Flotation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3175
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.