Cleared Traditional

K032291 - TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (FDA 510(k) Clearance)

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

K032291 · Linde Medical Sensors AG · Toxicology device
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Aug 2004
Decision
397d
Days
Class 2
Risk

K032291 is an FDA 510(k) clearance for the TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM. Classified as Radioimmunoassay, Digoxin (125-i), Goat Antibody, Anion Exchange, Resin Sep. (product code DOA), Class II - Special Controls.

Submitted by Linde Medical Sensors AG (Basel, CH). The FDA issued a Cleared decision on August 24, 2004 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K032291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2003
Decision Date August 24, 2004
Days to Decision 397 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
310d slower than avg
Panel avg: 87d · This submission: 397d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DOA Radioimmunoassay, Digoxin (125-i), Goat Antibody, Anion Exchange, Resin Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 Toxicology devices follow this clearance model.