Cleared Traditional

K973646 - BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER

K973646 is an FDA 510(k) clearance for BIRD SENTRY BLENDER/ ANALYZER / BIRD SE..., 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 225-day FDA review.

K973646 · Bird Products Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
225d
Days
Class 2
Risk

K973646 is an FDA 510(k) clearance for the BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER. 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 May 7, 1998 after a review of 225 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 - K973646

510(k) Number K973646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1997
Decision Date May 07, 1998
Days to Decision 225 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 140d · This submission: 225d
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 43
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K973646.
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · Mallard Medical, Inc. · Aug 2000
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · Sechrist Industries, Inc. · Aug 1999
ALADDIN II MONITORING OXYGEN/AIR MONITOR
K990293 · Hamilton Medical, Inc. · Mar 1999
AIR OXYGE MIXER
K974372 · Sk Med · Feb 1998
ALADDIN MONITORING OXYGEN/AIR MIXER
K960359 · Hamilton Medical, Inc. · Apr 1996
AIR ENTRAINER 900RT008
K953711 · Fisher & Paykel Electronics , Ltd. · Nov 1995