Cleared Traditional

K080063 - MASS CASUALTY VENTILATOR

K080063 is an FDA 510(k) clearance for MASS CASUALTY VENTILATOR, manufactured by Allied Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K080063 · Allied Healthcare Products, Inc. · Anesthesiology device
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Aug 2008
Decision
218d
Days
Class 2
Risk

K080063 is an FDA 510(k) clearance for the MASS CASUALTY VENTILATOR, MODEL MCV100. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on August 15, 2008 after a review of 218 days - an extended review cycle.

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.

View all Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K080063

510(k) Number K080063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2008
Decision Date August 15, 2008
Days to Decision 218 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 140d · This submission: 218d
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 31
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K080063.
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · Allied Healthcare Products, Inc. · May 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K083507 · Allied Healthcare Products, Inc. · May 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · Allied Healthcare Products, Inc. · May 2009
VAR MONITOR
K073261 · Vortran Medical Technology 1, Inc. · May 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · Allied Healthcare Products, Inc. · Mar 2008
AUTOVENT 4000 WITH CPAP
K070636 · Allied Healthcare Products, Inc. · Jul 2007