Cleared Traditional

K955243 - BARIAIR

K955243 is an FDA 510(k) clearance for BARIAIR, 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 708-day FDA review.

K955243 · Kinetic Concepts, Inc. · General Hospital
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Oct 1997
Decision
708d
Days
Class 2
Risk

K955243 is an FDA 510(k) clearance for the BARIAIR. 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 October 23, 1997 after a review of 708 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K955243

510(k) Number K955243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1995
Decision Date October 23, 1997
Days to Decision 708 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
579d slower than avg
Panel avg: 129d · This submission: 708d
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 K955243.
SIMPULSE
K972549 · Kinetic Concepts, Inc. · Nov 1997
KT AIR BED
K970468 · Kinetic Concepts, Inc. · Sep 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