Cleared Traditional

K031643 - SPIROTEL, MODEL 29-1020

K031643 is an FDA 510(k) clearance for SPIROTEL, manufactured by Sdi Diagnostics, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K031643 · Sdi Diagnostics, Inc. · Anesthesiology device
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Dec 2003
Decision
196d
Days
Class 2
Risk

K031643 is an FDA 510(k) clearance for the SPIROTEL, MODEL 29-1020. 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 December 9, 2003 after a review of 196 days - an extended review 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: 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.

FDA 510(k) Submission Details - K031643

510(k) Number K031643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date December 09, 2003
Days to Decision 196 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
56d slower than avg
Panel avg: 140d · This submission: 196d
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 158
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K031643.
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