Cleared Traditional

K083507 - BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS

K083507 is an FDA 510(k) clearance for BATTERY PACK FOR MCV100 AND MCV200 EMER..., 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 173-day FDA review.

K083507 · Allied Healthcare Products, Inc. · Anesthesiology device
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May 2009
Decision
173d
Days
Class 2
Risk

K083507 is an FDA 510(k) clearance for the BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS. 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 May 18, 2009 after a review of 173 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 - K083507

510(k) Number K083507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2008
Decision Date May 18, 2009
Days to Decision 173 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
33d slower than avg
Panel avg: 140d · This submission: 173d
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 78
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K083507.
MOVES
K093261 · Thornhill Research, Inc. · Mar 2010
ISPIRA RESUSCITATION UNIT
K092085 · Neoforce Group, Inc. · Oct 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · Allied Healthcare Products, Inc. · May 2009
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