Cleared Traditional

K960035 - CARBON DIOXIDE - DST

K960035 is an FDA 510(k) clearance for CARBON DIOXIDE - DST, manufactured by Trace America, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K960035

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
Combination Product No
PCCP Authorized No
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.

KHS Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K960035.
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
CO2
K981231 · Abbott Mfg., Inc. · May 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