Cleared Special

K051889 - CAREVENT CA AND DRA

K051889 is an FDA 510(k) clearance for CAREVENT CA AND DRA, manufactured by O-Two Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Special 510(k) pathway after a 49-day FDA review.

K051889 · O-Two Medical Technologies, Inc. · Anesthesiology device
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Aug 2005
Decision
49d
Days
Class 2
Risk

K051889 is an FDA 510(k) clearance for the CAREVENT CA AND DRA. 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 August 30, 2005 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051889

510(k) Number K051889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2005
Decision Date August 30, 2005
Days to Decision 49 days
Submission Type Special
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
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 80
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K051889.
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210 · Ohmeda Medical · Apr 2007
UNI-VENT MODEL 73X
K051476 · Impact Instrumentation, Inc. · Oct 2005
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K051469 · O-Two Medical Technologies, Inc. · Sep 2005
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K051322 · Smiths Medical International , Ltd. · Aug 2005
BABYPAC
K043495 · Smiths Medical International Ltd., Luton · Apr 2005
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K041473 · Vortran Medical Technology 1, Inc. · Jul 2004