Cleared Traditional

K013812 - SPIROLAB II, MODEL 29 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013812 · Sdi Diagnostics, Inc. · Anesthesiology device
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Feb 2002
Decision
88d
Days
Class 2
Risk

K013812 is an FDA 510(k) clearance for the SPIROLAB II, MODEL 29. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Sdi Diagnostics, Inc. (Easton, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 88 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 Sdi Diagnostics, Inc. devices

Submission Details

510(k) Number K013812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date February 11, 2002
Days to Decision 88 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
51d faster than avg
Panel avg: 139d · This submission: 88d
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.

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