Cleared Traditional

K911962 - BIRD SENTRY AIR/OXYGEN MICROBLENDER

K911962 is the FDA 510(k) clearance for BIRD SENTRY AIR/OXYGEN MICROBLENDER by Bird Products Corp.. It is a Class 2 Anesthesiology device (product code BZR) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K911962 · Bird Products Corp. · Anesthesiology device
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Oct 1991
Decision
159d
Days
Class 2
Risk

K911962 is an FDA 510(k) clearance for the BIRD SENTRY AIR/OXYGEN MICROBLENDER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 159 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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

Submission Details

510(k) Number K911962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1991
Decision Date October 08, 1991
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 13
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K911962.
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