Cleared Special

K020746 - BIRD TBIRD VELA VENTILATOR

K020746 is an FDA 510(k) clearance for BIRD TBIRD VELA VENTILATOR, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 46-day FDA review.

K020746 · Bird Products Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
46d
Days
Class 2
Risk

K020746 is an FDA 510(k) clearance for the BIRD TBIRD VELA VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on April 22, 2002 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K020746

510(k) Number K020746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date April 22, 2002
Days to Decision 46 days
Submission Type Special
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
94d faster than avg
Panel avg: 140d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K020746.
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
AVEA
K013642 · Bird Products Corp. · May 2002
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · Siemens Elema AB · Dec 2001
BIRD TBIRD LEGACY VENTILATOR
K003770 · Bird Products Corp. · Dec 2000
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K001646 · Puritan Bennett Corp. · Oct 2000