Cleared Traditional

K961854 - SPR PLUS II OVERLAY SYSTEM (CL250/CL212

K961854 is the FDA 510(k) clearance for SPR PLUS II OVERLAY SYSTEM (CL250/CL212 by Gaymar Industries, Inc.. It is a Class 2 General Hospital device (product code FNM) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K961854 · Gaymar Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
87d
Days
Class 2
Risk

K961854 is an FDA 510(k) clearance for the SPR PLUS II OVERLAY SYSTEM (CL250/CL212. 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 August 9, 1996 after a review of 87 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 K961854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date August 09, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
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 K961854.
BARIAIR
K955243 · Kinetic Concepts, Inc. · Oct 1997
KT AIR BED
K970468 · Kinetic Concepts, Inc. · Sep 1997
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411 · Invacare Corp. · Mar 1996
TRIADYNE
K944094 · Kinetic Concepts, Inc. · May 1995
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994