Cleared Traditional

K051469 - CAREVENT ATV+ AND CAREVENT MRI

K051469 is an FDA 510(k) clearance for CAREVENT ATV+ AND CAREVENT MRI, manufactured by O-Two Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K051469 · O-Two Medical Technologies, Inc. · Anesthesiology device
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Sep 2005
Decision
117d
Days
Class 2
Risk

K051469 is an FDA 510(k) clearance for the CAREVENT ATV+ AND CAREVENT MRI. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by O-Two Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 28, 2005 after a review of 117 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 O-Two Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K051469

510(k) Number K051469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date September 28, 2005
Days to Decision 117 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 140d · This submission: 117d
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 48
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K051469.
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
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K041473 · Vortran Medical Technology 1, Inc. · Jul 2004
COMPPAC 200HD
K040090 · Pneupac , Ltd. · May 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386 · Impact Instrumentation, Inc. · Mar 2004