Cleared Traditional

K933004 - PEGASUS BIWAVE SYSTEM

K933004 is an FDA 510(k) clearance for PEGASUS BIWAVE SYSTEM, manufactured by Pegasus Airwave, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K933004 · Pegasus Airwave, Inc. · General Hospital
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Mar 1994
Decision
259d
Days
Class 2
Risk

K933004 is an FDA 510(k) clearance for the PEGASUS BIWAVE SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Pegasus Airwave, Inc. (Deerfield Beach, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 259 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 Pegasus Airwave, Inc. devices

FDA 510(k) Submission Details - K933004

510(k) Number K933004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1993
Decision Date March 07, 1994
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 129d · This submission: 259d
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 K933004.
PRESSUREGUARD IV
K951112 · Span-America Medical Systems, Inc. · Jun 1995
TRIADYNE
K944094 · Kinetic Concepts, Inc. · May 1995
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