Cleared Traditional

K912412 - VITALOGRAPH SPIROTRAC III

K912412 is an FDA 510(k) clearance for VITALOGRAPH SPIROTRAC III, manufactured by Vitalograph , Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K912412 · Vitalograph , Ltd. · Anesthesiology device
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Oct 1991
Decision
137d
Days
Class 2
Risk

K912412 is an FDA 510(k) clearance for the VITALOGRAPH SPIROTRAC III. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 137 days - within the typical 510(k) review window.

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 Vitalograph , Ltd. devices

FDA 510(k) Submission Details - K912412

510(k) Number K912412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date October 15, 1991
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
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 65
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K912412.
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111 · Sensor Medics Corp. · Oct 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · Sensor Medics Corp. · Apr 1992
AIRWAY THERMISTOR
K914219 · Synectics-Dantec · Feb 1992
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K904625 · Synectics-Dantec · Aug 1991
SPIROSIFT 500A
K904200 · Fukuda Denshi USA, Inc. · May 1991
SPIRO ANALYZER MODEL ST 250
K901308 · Futuremed Div. of Future Impex Corp. · Jul 1990