Cleared Traditional

K070636 - AUTOVENT 4000 WITH CPAP

K070636 is an FDA 510(k) clearance for AUTOVENT 4000 WITH CPAP, 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 128-day FDA review.

K070636 · Allied Healthcare Products, Inc. · Anesthesiology device
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Jul 2007
Decision
128d
Days
Class 2
Risk

K070636 is an FDA 510(k) clearance for the AUTOVENT 4000 WITH CPAP. 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 July 13, 2007 after a review of 128 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.

View all Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K070636

510(k) Number K070636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2007
Decision Date July 13, 2007
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 K070636.
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
AUTOVENT MODEL 4000
K070120 · Allied Healthcare Products, Inc. · May 2007
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210 · Ohmeda Medical · Apr 2007
UNI-VENT MODEL 73X
K051476 · Impact Instrumentation, Inc. · Oct 2005