Cleared Traditional

K961252 - DSXL DIFFUSION SPIROMETER

K961252 is the FDA 510(k) clearance for DSXL DIFFUSION SPIROMETER by Inair , Ltd.. It is a Class 2 Anesthesiology device (product code BTY) cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K961252 · Inair , Ltd. · Anesthesiology device
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Feb 1997
Decision
319d
Days
Class 2
Risk

K961252 is an FDA 510(k) clearance for the DSXL DIFFUSION SPIROMETER. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Inair , Ltd. (Delmar, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Inair , Ltd. devices

Submission Details

510(k) Number K961252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date February 14, 1997
Days to Decision 319 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
179d slower than avg
Panel avg: 140d · This submission: 319d
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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