Cleared Traditional

K960035 - CARBON DIOXIDE - DST

K960035 is the FDA 510(k) clearance for CARBON DIOXIDE - DST by Trace America, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K960035 · Trace America, Inc. · Chemistry device
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Apr 1996
Decision
96d
Days
Class 2
Risk

K960035 is an FDA 510(k) clearance for the CARBON DIOXIDE - DST. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on April 8, 1996 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Trace America, Inc. devices

Submission Details

510(k) Number K960035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1996
Decision Date April 08, 1996
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 Chemistry devices follow this clearance model.

Regulatory Peers - KHS Enzymatic, Carbon-dioxide

All 66
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K960035.
RAICHEM CO2 REAGENT
K982056 · Reagents Applications, Inc. · Jun 1998
CO2
K981840 · Abbott Laboratories · Jun 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · Roche Diagnostic Systems, Inc. · Jun 1998
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · Synermed, Inc. · Mar 1996
SERUM BICARBONATE/CARBON DIOXIDE
K955302 · Data Medical Associates, Inc. · Feb 1996
TOTAL CO2
K951221 · Randox Laboratories, Ltd. · Feb 1996