Cleared Traditional

K912234 - SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION

K912234 is an FDA 510(k) clearance for SOMNIPROBE MODEL NUMBER 10093, manufactured by Somnitec, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K912234 · Somnitec, Inc. · Anesthesiology device
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Jul 1991
Decision
66d
Days
Class 2
Risk

K912234 is an FDA 510(k) clearance for the SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Somnitec, Inc. (Van Nuys, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Somnitec, Inc. devices

FDA 510(k) Submission Details - K912234

510(k) Number K912234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date July 22, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K912234.
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