Cleared Traditional

K914485 - VENTILATOR STAND

K914485 is the FDA 510(k) clearance for VENTILATOR STAND by Bird Products Corp.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K914485 · Bird Products Corp. · Anesthesiology device
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Oct 1991
Decision
17d
Days
Class 2
Risk

K914485 is an FDA 510(k) clearance for the VENTILATOR STAND. 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 October 25, 1991 after a review of 17 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

Submission Details

510(k) Number K914485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date October 25, 1991
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 121
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K914485.
PURITAN-BENNETT MODEL 7200AE VENTILATOR
K923809 · Puritan Bennett Corp. · Oct 1992
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K915312 · Puritan Bennett Corp. · Jul 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991