Cleared Traditional

K933965 - APEX MEDICAL AIR PUMPS

K933965 is the FDA 510(k) clearance for APEX MEDICAL AIR PUMPS by Apex Medical, Inc.. It is a Class 2 General Hospital device (product code FNM) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K933965 · Apex Medical, Inc. · General Hospital
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Mar 1994
Decision
213d
Days
Class 2
Risk

K933965 is an FDA 510(k) clearance for the APEX MEDICAL AIR PUMPS. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Apex Medical, Inc. (Santa Monica, US). The FDA issued a Cleared decision on March 17, 1994 after a review of 213 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 Apex Medical, Inc. devices

Submission Details

510(k) Number K933965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date March 17, 1994
Days to Decision 213 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
84d slower than avg
Panel avg: 129d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K933965.
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411 · Invacare Corp. · Mar 1996
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