Cleared Traditional

K904118 - SOMNIPROBE II NASAL AND BUCCAL AIRFLOW ...

K904118 is the FDA 510(k) clearance for SOMNIPROBE II NASAL AND BUCCAL AIRFLOW ... by Dawn Medical. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K904118 · Dawn Medical · Anesthesiology device
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Feb 1991
Decision
172d
Days
Class 2
Risk

K904118 is an FDA 510(k) clearance for the SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Dawn Medical (San Francisco, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 172 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Dawn Medical devices

Submission Details

510(k) Number K904118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date February 25, 1991
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 140d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 30
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K904118.
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