Cleared Traditional

K933262 - BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903

K933262 is an FDA 510(k) clearance for BIRD AVIAN PORT MILITARY VENT NSN 6530-..., 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 23-day FDA review.

K933262 · Bird Products Corp. · Anesthesiology device
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Jul 1993
Decision
23d
Days
Class 2
Risk

K933262 is an FDA 510(k) clearance for the BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903. 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 July 29, 1993 after a review of 23 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K933262

510(k) Number K933262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date July 29, 1993
Days to Decision 23 days
Submission Type Traditional
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
117d faster than avg
Panel avg: 140d · This submission: 23d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K933262.
BABYLOG 8000 INFANT VENTILATOR
K926292 · Drager, Inc. · Apr 1994
BIRD 8400TI ADULT VOLUME VENTILATOR
K930747 · Bird Products Corp. · Feb 1994
EVITA
K924930 · Drager, Inc. · Jan 1994
POWER PACK 350/BATTERY PACK 351
K923992 · Siemens Medical Solutions USA, Inc. · Apr 1993
BIRD 8400ST ADULT VOLUME VENTILATOR
K921387 · Bird Products Corp. · Mar 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993