Cleared Traditional

SOFT-COVER (K921928) - FDA 510(k) Clearance

Class I General Hospital device.

K921928 · Adroit Medical Systems, Inc. · General Hospital
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Nov 1992
Decision
196d
Days
Class 1
Risk

K921928 is an FDA 510(k) clearance for the SOFT-COVER. Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by Adroit Medical Systems, Inc. (Morganton, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 196 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6190 - 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 Adroit Medical Systems, Inc. devices

Submission Details

510(k) Number K921928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1992
Decision Date November 06, 1992
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMW Cover, Mattress (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
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.