Cleared Traditional

K080922 - SALTER LABS ORAL/NASAL THERMAL AIRFLOW ...

K080922 is an FDA 510(k) clearance for SALTER LABS ORAL/NASAL THERMAL AIRFLOW ..., manufactured by Salter Labs, Division of Regulatory Affairs. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K080922 · Salter Labs, Division of Regulatory Affairs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
115d
Days
Class 2
Risk

K080922 is an FDA 510(k) clearance for the SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Salter Labs, Division of Regulatory Affairs (Arvin, US). The FDA issued a Cleared decision on July 25, 2008 after a review of 115 days - within the typical 510(k) review window.

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.

View all Salter Labs, Division of Regulatory Affairs devices

FDA 510(k) Submission Details - K080922

510(k) Number K080922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date July 25, 2008
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
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 78
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K080922.
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