Cleared Traditional

K970468 - KT AIR BED

K970468 is an FDA 510(k) clearance for KT AIR BED, manufactured by Kinetic Concepts, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K970468 · Kinetic Concepts, Inc. · General Hospital
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Sep 1997
Decision
210d
Days
Class 2
Risk

K970468 is an FDA 510(k) clearance for the KT AIR BED. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 210 days - an extended review 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: 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 Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K970468

510(k) Number K970468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1997
Decision Date September 05, 1997
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K970468.
SIMPULSE
K972549 · Kinetic Concepts, Inc. · Nov 1997
BARIAIR
K955243 · Kinetic Concepts, Inc. · Oct 1997
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411 · Invacare Corp. · Mar 1996
BAZOOKA SYSTEM
K951469 · Innovative Medical Systems, Inc. · Jun 1995