Cleared Traditional

K822079 - ENZYMATIC CO2

K822079 is the FDA 510(k) clearance for ENZYMATIC CO2 by American Monitor Corp.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K822079 · American Monitor Corp. · Chemistry device
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Jul 1982
Decision
12d
Days
Class 2
Risk

K822079 is an FDA 510(k) clearance for the ENZYMATIC CO2. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by American Monitor Corp. (Walker, US). The FDA issued a Cleared decision on July 27, 1982 after a review of 12 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 American Monitor Corp. devices

Submission Details

510(k) Number K822079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1982
Decision Date July 27, 1982
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
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 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K822079.
ROCHE REAGENTS REAGENT FOR CO2
K844987 · Roche Diagnostic Systems, Inc. · Jan 1985
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
K841664 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1984
CARBON DIOXIDE REAGENT
K840773 · American Dade · Apr 1984
BICARBONATE TEST
K810356 · Boehringer Mannheim Corp. · Feb 1981
MULTISTAT III BICARBONATE TEST
K771507 · Instrumentation Laboratory CO · Oct 1977
REAGENT KIT, ENZYMATIC CO2
K760546 · Beckman Instruments, Inc. · Nov 1976