Cleared Traditional

K831497 - SPIROMETRICS BREON 2400 & SMI 2400

K831497 is the FDA 510(k) clearance for SPIROMETRICS BREON 2400 & SMI 2400 by Spirometrics, Inc.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K831497 · Spirometrics, Inc. · Anesthesiology device
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Jun 1983
Decision
45d
Days
Class 2
Risk

K831497 is an FDA 510(k) clearance for the SPIROMETRICS BREON 2400 & SMI 2400. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Spirometrics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 45 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 Spirometrics, Inc. devices

Submission Details

510(k) Number K831497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1983
Decision Date June 24, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
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.