Cleared Traditional

K882092 - CLINI-CARE + PRESSURE ULCER TREATMENT S...

K882092 is the FDA 510(k) clearance for CLINI-CARE + PRESSURE ULCER TREATMENT S... by Gaymar Industries, Inc.. It is a Class 2 General Hospital device (product code FNM) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K882092 · Gaymar Industries, Inc. · General Hospital
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Jul 1988
Decision
55d
Days
Class 2
Risk

K882092 is an FDA 510(k) clearance for the CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gaymar Industries, Inc. devices

Submission Details

510(k) Number K882092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date July 13, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FNM Mattress, Air Flotation, Alternating Pressure

All 12
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K882092.
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · Kinetic Concepts, Inc. · Oct 1990
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
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ABCO/GRANT ALTERNATING PRESSURE PAD & UT
K800231 · Abco Dealers, Inc. · Feb 1980
AERO PULSE ALTERNATING PRES. PUMP
K771463 · Medline Industries, Inc. · Aug 1977