Cleared Traditional

K926403 - PRO-2000 LOW AIR LOSS THERAPY BED

K926403 is an FDA 510(k) clearance for PRO-2000 LOW AIR LOSS THERAPY BED, manufactured by Ch Administration, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K926403 · Ch Administration, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
221d
Days
Class 2
Risk

K926403 is an FDA 510(k) clearance for the PRO-2000 LOW AIR LOSS THERAPY BED. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Ch Administration, Inc. (Dallas, US). The FDA issued a Cleared decision on July 30, 1993 after a review of 221 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 Ch Administration, Inc. devices

FDA 510(k) Submission Details - K926403

510(k) Number K926403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date July 30, 1993
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 K926403.
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994
PRESSUREGUARD IV
K932681 · Span-America Medical Systems, Inc. · Nov 1993
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993
SKYTRON LIFE ISLAND 21
K926045 · Skytron, Div. the Kmw Group, Inc. · Jul 1993
BIO THERAPY PLUS
K922205 · Sunrise Medical, Inc. · Aug 1992
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · Kinetic Concepts, Inc. · Oct 1990