Cleared Special

K003770 - BIRD TBIRD LEGACY VENTILATOR

K003770 is an FDA 510(k) clearance for BIRD TBIRD LEGACY 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 9-day FDA review.

K003770 · Bird Products Corp. · Anesthesiology device
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Dec 2000
Decision
9d
Days
Class 2
Risk

K003770 is an FDA 510(k) clearance for the BIRD TBIRD LEGACY 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 December 15, 2000 after a review of 9 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 - K003770

510(k) Number K003770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 06, 2000
Decision Date December 15, 2000
Days to Decision 9 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
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 K003770.
AVEA
K013642 · Bird Products Corp. · May 2002
BIRD TBIRD VELA VENTILATOR
K020746 · Bird Products Corp. · Apr 2002
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · Siemens Elema AB · Dec 2001
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K001646 · Puritan Bennett Corp. · Oct 2000
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
K002686 · Nellcor Puritan Bennett, Inc. · Oct 2000
ESPIRT
K001208 · Respironics, Inc. · May 2000