Cleared Traditional

K990962 - FLOSENSE

K990962 is an FDA 510(k) clearance for FLOSENSE, manufactured by Sdi Diagnostics, Inc.. The device is a Class 2 Anesthesiology device with product code JAX cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K990962 · Sdi Diagnostics, Inc. · Anesthesiology device
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Jan 2000
Decision
291d
Days
Class 2
Risk

K990962 is an FDA 510(k) clearance for the FLOSENSE, MODEL 29-8010. Classified as Pneumotachometer (product code JAX), Class II - Special Controls.

Submitted by Sdi Diagnostics, Inc. (Easton, US). The FDA issued a Cleared decision on January 7, 2000 after a review of 291 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2550 - 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.

View all Sdi Diagnostics, Inc. devices

FDA 510(k) Submission Details - K990962

510(k) Number K990962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date January 07, 2000
Days to Decision 291 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
151d slower than avg
Panel avg: 140d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAX Device Classification - Class 2, Special Controls

Product Code JAX Pneumotachometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2550
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.