Cleared Traditional

K954320 - MODIFIED PEDIKAIR

K954320 is an FDA 510(k) clearance for MODIFIED PEDIKAIR, 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 680-day FDA review.

K954320 · Kinetic Concepts, Inc. · General Hospital
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Jul 1997
Decision
680d
Days
Class 2
Risk

K954320 is an FDA 510(k) clearance for the MODIFIED PEDIKAIR. 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 July 18, 1997 after a review of 680 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 - K954320

510(k) Number K954320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1995
Decision Date July 18, 1997
Days to Decision 680 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
551d slower than avg
Panel avg: 129d · This submission: 680d
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 52
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K954320.
KT AIR BED
K970468 · Kinetic Concepts, Inc. · Sep 1997
RID-DECUBE II
K965207 · Skin Care Management, Inc. · Aug 1997
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
K972153 · Decubiti Concepts, Inc. · Jul 1997
REST MATTRESS
K971568 · Rest Mattress · Jul 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362 · Apex Metal, Inc. · May 1997
REST X SYSTEM
K970428 · Restxsys · May 1997