Cleared Traditional

K970362 - CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM

K970362 is an FDA 510(k) clearance for CARE TEC PORTABLE LOW AIR LOSS THERAPY ..., manufactured by Apex Metal, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K970362 · Apex Metal, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
105d
Days
Class 2
Risk

K970362 is an FDA 510(k) clearance for the CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Apex Metal, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 16, 1997 after a review of 105 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 Apex Metal, Inc. devices

FDA 510(k) Submission Details - K970362

510(k) Number K970362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date May 16, 1997
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
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 40
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K970362.
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
K972153 · Decubiti Concepts, Inc. · Jul 1997
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
REST MATTRESS
K971568 · Rest Mattress · Jul 1997
REST X SYSTEM
K970428 · Restxsys · May 1997
EQUI-PISE 1000 MRS
K970350 · Advanced Air Support Consultancy, Inc. · Apr 1997
PRESSUREGUARD: SELECTCARE
K960188 · Span-America Medical Systems, Inc. · Oct 1996