Cleared Traditional

K992475 - CARESIDE CO2

K992475 is the FDA 510(k) clearance for CARESIDE CO2 by Careside, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K992475 · Careside, Inc. · Chemistry device
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Sep 1999
Decision
51d
Days
Class 2
Risk

K992475 is an FDA 510(k) clearance for the CARESIDE CO2, TOTAL. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on September 15, 1999 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Careside, Inc. devices

Submission Details

510(k) Number K992475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date September 15, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 K992475.
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc. · Mar 2001
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · Diagnostic Chemicals , Ltd. · Sep 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · Ortho-Clinical Diagnostics, Inc. · Apr 2000
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · Diagnostic Chemicals , Ltd. · Apr 1999
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · Diagnostic Chemicals , Ltd. · Sep 1998
RAICHEM CO2 REAGENT
K982056 · Reagents Applications, Inc. · Jun 1998