Cleared Traditional

K850045 - SPIROMETRICS 2453 & SMI III

K850045 is the FDA 510(k) clearance for SPIROMETRICS 2453 & SMI III by Spirometrics, Inc.. It is a Class 2 Anesthesiology device (product code BTY) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K850045 · Spirometrics, Inc. · Anesthesiology device
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Feb 1985
Decision
38d
Days
Class 2
Risk

K850045 is an FDA 510(k) clearance for the SPIROMETRICS 2453 & SMI III. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Spirometrics, Inc. (Andover, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 K850045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1985
Decision Date February 14, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 140d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

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