Cleared Traditional

K851027 - SOF. CARE CUSHION & SOF-CARE CUSHION COVER

K851027 is an FDA 510(k) clearance for SOF. CARE CUSHION & SOF-CARE CUSHION COVER, manufactured by Gaymar Industries, Inc.. The device is a Class 1 Physical Medicine device with product code KIC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

FDA 510(k) Submission Details - K851027

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

KIC Device Classification - Class 1, General Controls

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.

Regulatory Peers - KIC Cushion, Flotation

All 11
Devices cleared under the same product code (KIC) and FDA review panel - the closest regulatory comparables to K851027.
GEL CUSHION
K941858 · Hollister, Inc. · May 1994
PUSH CUSH
K864108 · Medical Industries America, Inc. · Nov 1986
C' AIRECUSH SEAT CUSHION
K864109 · Medical Industries America, Inc. · Nov 1986
PRESSURE RELIEF SEAT CUSHION
K842380 · American Pharmaseal Div. Ahsc · Jun 1984
INFLATABLE INVALID RING
K830426 · Maddak, Inc. · Apr 1983
ARM CUSHION
K830427 · Maddak, Inc. · Mar 1983