Cleared Traditional

K921928 - SOFT-COVER

K921928 is an FDA 510(k) clearance for SOFT-COVER, manufactured by Adroit Medical Systems, Inc.. The device is a Class 1 General Hospital device with product code FMW cleared through the Traditional 510(k) pathway after a 196-day FDA review.

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.

FDA 510(k) Submission Details - K921928

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.

FMW Device Classification - Class 1, General Controls

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.

Regulatory Peers - FMW Cover, Mattress (medical Purposes)

All 12
Devices cleared under the same product code (FMW) and FDA review panel - the closest regulatory comparables to K921928.
CORE PREVENT MATTRESS MODIFICATION
K935220 · Paladin Medical, Inc. · Nov 1993
REUSABLE INCONTIENT UNDERPAD
K924807 · Perfect Fit Industries, Inc. · Feb 1993
WIPEABLE PILLOW
K924477 · Perfect Fit Industries, Inc. · Jan 1993
OBALON COVER
K923173 · Turnsoft, Inc. · Nov 1992
ALLERGY CONTROL COVERS
K903382 · Allergy Control Products, Inc. · Nov 1990
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
K902446 · Mallinckrodt Group, Inc. · Aug 1990
K921928 · SOFT-COVER
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