Cleared Traditional

K032386 - UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

K032386 is an FDA 510(k) clearance for UNI-VENT MODEL 730AEV (AUTOMATIC EMERGE..., manufactured by Impact Instrumentation, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K032386 · Impact Instrumentation, Inc. · Anesthesiology device
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Mar 2004
Decision
235d
Days
Class 2
Risk

K032386 is an FDA 510(k) clearance for the UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR). Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on March 26, 2004 after a review of 235 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 Impact Instrumentation, Inc. devices

FDA 510(k) Submission Details - K032386

510(k) Number K032386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date March 26, 2004
Days to Decision 235 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
95d slower than avg
Panel avg: 140d · This submission: 235d
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 K032386.
BABYPAC
K043495 · Smiths Medical International Ltd., Luton · Apr 2005
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
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COMPPAC 200HD
K040090 · Pneupac , Ltd. · May 2004
PARAPAC 200D TRANSPORT, MODEL V200D
K030803 · Pneupac , Ltd. · Sep 2003
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
K021841 · Pneupac , Ltd. · Jul 2003
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
K020899 · Pneupac , Ltd. · Dec 2002