Cleared Traditional

K093094 - VELA VENTILATOR

K093094 is an FDA 510(k) clearance for VELA VENTILATOR, manufactured by Cardinal Health 207, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K093094 · Cardinal Health 207, Inc. · Anesthesiology device
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May 2010
Decision
222d
Days
Class 2
Risk

K093094 is an FDA 510(k) clearance for the VELA VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Cardinal Health 207, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 222 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Cardinal Health 207, Inc. devices

FDA 510(k) Submission Details - K093094

510(k) Number K093094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date May 11, 2010
Days to Decision 222 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
82d slower than avg
Panel avg: 140d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K093094.
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010
NEWPORT E360 VENTILATOR
K101803 · Newport Medical Instruments, Inc. · Sep 2010
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
HAMILTON-C2
K092148 · Hamilton Medical AG · Mar 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
K092648 · Respironics Inc., Sleep & Home Respiratory Group · Dec 2009