Cleared Traditional

K033939 - FLOSENSE II, MODEL 29-8040

K033939 is an FDA 510(k) clearance for FLOSENSE II, 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 46-day FDA review.

K033939 · Sdi Diagnostics, Inc. · Anesthesiology device
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Jan 2004
Decision
46d
Days
Class 2
Risk

K033939 is an FDA 510(k) clearance for the FLOSENSE II, MODEL 29-8040. 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 January 30, 2004 after a review of 46 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.

FDA 510(k) Submission Details - K033939

510(k) Number K033939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2003
Decision Date January 30, 2004
Days to Decision 46 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
94d faster than avg
Panel avg: 140d · This submission: 46d
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
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