Cleared Traditional

K981445 - ULTIMA AIRFLOW SENSOR, 0510

K981445 is an FDA 510(k) clearance for ULTIMA AIRFLOW SENSOR, manufactured by Braebon Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K981445 · Braebon Medical Corp. · Anesthesiology device
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Oct 1998
Decision
166d
Days
Class 2
Risk

K981445 is an FDA 510(k) clearance for the ULTIMA AIRFLOW SENSOR, 0510. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Braebon Medical Corp. (Kanata, CA). The FDA issued a Cleared decision on October 5, 1998 after a review of 166 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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.

FDA 510(k) Submission Details - K981445

510(k) Number K981445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1998
Decision Date October 05, 1998
Days to Decision 166 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
26d slower than avg
Panel avg: 140d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 118
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K981445.
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K983449 · Gereonics, Inc. · Feb 1999
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K981725 · Optovent, Inc. · Feb 1999
ULTIMA AIRFLOW PRESSURE SENSOR
K984431 · Braebon Medical Corp. · Dec 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
K982216 · Braebon Medical Corp. · Sep 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K981728 · Alexander Mfg. Co. · Jun 1998