Cleared Special

K984431 - ULTIMA AIRFLOW PRESSURE SENSOR

K984431 is an FDA 510(k) clearance for ULTIMA AIRFLOW PRESSURE SENSOR, manufactured by Braebon Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Special 510(k) pathway after a 19-day FDA review.

K984431 · Braebon Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
19d
Days
Class 2
Risk

K984431 is an FDA 510(k) clearance for the ULTIMA AIRFLOW PRESSURE SENSOR. 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 December 30, 1998 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K984431

510(k) Number K984431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1998
Decision Date December 30, 1998
Days to Decision 19 days
Submission Type Special
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
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 K984431.
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411 · Gereonics, Inc. · Apr 1999
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 SENSOR, 0510
K981445 · Braebon Medical Corp. · Oct 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