Cleared Traditional

K951221 - TOTAL CO2

K951221 is an FDA 510(k) clearance for TOTAL CO2, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K951221 · Randox Laboratories, Ltd. · Chemistry device
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Feb 1996
Decision
332d
Days
Class 2
Risk

K951221 is an FDA 510(k) clearance for the TOTAL CO2. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on February 15, 1996 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K951221

510(k) Number K951221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date February 15, 1996
Days to Decision 332 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
244d slower than avg
Panel avg: 88d · This submission: 332d
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 K951221.
CARBON DIOXIDE - DST
K960035 · Trace America, Inc. · Apr 1996
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · Synermed, Inc. · Mar 1996
SERUM BICARBONATE/CARBON DIOXIDE
K955302 · Data Medical Associates, Inc. · Feb 1996
CARBON DIOXIDE - DST
K952410 · Trace America, Inc. · Oct 1995
CARBON DIOXIDE (C02)
K942735 · Teco Diagnostics · Mar 1995
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994