Cleared Traditional

CARBON DIOXIDE (C02) (K942735) - FDA 510(k) Clearance

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

K942735 · Teco Diagnostics · Chemistry device
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Mar 1995
Decision
283d
Days
Class 2
Risk

K942735 is an FDA 510(k) clearance for the CARBON DIOXIDE (C02). Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on March 20, 1995 after a review of 283 days - an extended review cycle.

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 Teco Diagnostics devices

Submission Details

510(k) Number K942735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1994
Decision Date March 20, 1995
Days to Decision 283 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
195d slower than avg
Panel avg: 88d · This submission: 283d
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 41
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K942735.
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · Roche Diagnostic Systems, Inc. · Jun 1998
SERUM BICARBONATE/CARBON DIOXIDE
K955302 · Data Medical Associates, Inc. · Feb 1996
TOTAL CO2
K951221 · Randox Laboratories, Ltd. · Feb 1996
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994
BICARBONATE
K931887 · Em Diagnostic Systems, Inc. · Aug 1993
BICARBONATE
K924711 · Em Diagnostic Systems, Inc. · Dec 1992