Cleared Traditional

K900722 - LOW FLOW N2O/02O MICROBLENDER

K900722 is an FDA 510(k) clearance for LOW FLOW N2O/02O MICROBLENDER, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K900722 · Bird Products Corp. · Anesthesiology device
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Jul 1990
Decision
154d
Days
Class 2
Risk

K900722 is an FDA 510(k) clearance for the LOW FLOW N2O/02O 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 July 18, 1990 after a review of 154 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

FDA 510(k) Submission Details - K900722

510(k) Number K900722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1990
Decision Date July 18, 1990
Days to Decision 154 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
14d slower than avg
Panel avg: 140d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K900722.
PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM
K932709 · Precision Med Products, Ltd. · Jul 1993
HYPERINFLATION SYSTEM
K932557 · Life Shield Healthcare Products, Inc. · Jul 1993
BIRD SENTRY AIR/OXYGEN MICROBLENDER
K911962 · Bird Products Corp. · Oct 1991
BIRD MICROBLENDER M.R.I.
K895695 · Bird Products Corp. · Jul 1990
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
K883038 · Bird Products Corp. · Nov 1988
SIEMENS O2-AIR MIXER 965
K872278 · Siemens Elema AB · Sep 1987