Cleared Traditional

K083507 - BATTERY PACK FOR MCV100 AND MCV200 EMER...

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 31
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K083507.
EMERGENCY PORTABLE VENTILATOR
K131098 · Allied Healthcare Products, Inc. · Apr 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021 · Allied Healthcare Products, Inc. · Apr 2014
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
MASS CASUALTY VENTILATOR, MODEL MCV100
K080063 · Allied Healthcare Products, Inc. · Aug 2008
VAR MONITOR
K073261 · Vortran Medical Technology 1, Inc. · May 2008