Cleared Traditional

K080692 - MACS CPAP SYSTEM

K080692 is an FDA 510(k) clearance for MACS CPAP SYSTEM, manufactured by Airon Corporation. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K080692 · Airon Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
101d
Days
Class 2
Risk

K080692 is an FDA 510(k) clearance for the MACS CPAP SYSTEM. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Airon Corporation (Melbourne, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080692

510(k) Number K080692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date June 20, 2008
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTL Ventilator, Emergency, Powered (resuscitator)

All 80
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K080692.
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · Allied Healthcare Products, Inc. · May 2009
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
K081330 · O-Two Medical Technologies, Inc. · Mar 2009
MASS CASUALTY VENTILATOR, MODEL MCV100
K080063 · Allied Healthcare Products, Inc. · Aug 2008
VAR MONITOR
K073261 · Vortran Medical Technology 1, Inc. · May 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · Allied Healthcare Products, Inc. · Mar 2008
PNEUPAC VR1 AIR MIX
K071527 · Smiths Medical International , Ltd. · Oct 2007