Cleared Traditional

K922205 - BIO THERAPY PLUS

K922205 is an FDA 510(k) clearance for BIO THERAPY PLUS, manufactured by Sunrise Medical, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K922205 · Sunrise Medical, Inc. · General Hospital
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Aug 1992
Decision
91d
Days
Class 2
Risk

K922205 is an FDA 510(k) clearance for the BIO THERAPY PLUS. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Sunrise Medical, Inc. (Ontario, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 91 days - within the typical 510(k) review window.

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 Sunrise Medical, Inc. devices

FDA 510(k) Submission Details - K922205

510(k) Number K922205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1992
Decision Date August 11, 1992
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 21
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K922205.
TRIADYNE
K944094 · Kinetic Concepts, Inc. · May 1995
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · Kinetic Concepts, Inc. · Oct 1990
HUNTLEIGH DYNAMIC FLOTATION SYSTEM
K890012 · Huntleigh Technology, Inc. · Mar 1989
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
K882644 · Huntleigh Technology, Inc. · Aug 1988