Cleared Traditional

K863228 - BIRD 6400ST VOLUME VENTILATOR

K863228 is an FDA 510(k) clearance for BIRD 6400ST VOLUME VENTILATOR, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K863228 · Bird Products Corp. · Anesthesiology device
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Feb 1987
Decision
173d
Days
Class 2
Risk

K863228 is an FDA 510(k) clearance for the BIRD 6400ST VOLUME 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 February 10, 1987 after a review of 173 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 Bird Products Corp. devices

FDA 510(k) Submission Details - K863228

510(k) Number K863228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1986
Decision Date February 10, 1987
Days to Decision 173 days
Submission Type Traditional
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
33d slower than avg
Panel avg: 140d · This submission: 173d
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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K863228.
BEAR JET VENTILATOR FOR USE DURING (ESWL)
K871985 · Bear Medical Systems, Inc. · Jun 1987
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · Puritan Bennett Corp. · Mar 1987
PEDIATRIC BELLOWS
K864431 · Draeger Medical, Inc. · Jan 1987
OHMEDA 7400 ANESTHESIA VENTILATOR
K864129 · Ohmeda Medical · Dec 1986
EMERSON 3MV VOLUME VENTILATOR
K864379 · J. H. Emerson Co. · Dec 1986