Cleared Traditional

SCM-3 AND ACCESSORIES (K914921) - FDA 510(k) Clearance

Class I General Hospital device.

K914921 · Gaymar Industries, Inc. · General Hospital
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Mar 1992
Decision
129d
Days
Class 1
Risk

K914921 is an FDA 510(k) clearance for the SCM-3 AND ACCESSORIES. Classified as Mattress, Flotation Therapy, Non-powered (product code IKY), Class I - General Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on March 12, 1992 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5150 - 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 Gaymar Industries, Inc. devices

Submission Details

510(k) Number K914921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date March 12, 1992
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IKY Mattress, Flotation Therapy, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5150
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.