Cleared Traditional

K863544 - EASY-TEST CARBON DIOXIDE (CO2) ITEM #67...

K863544 is the FDA 510(k) clearance for EASY-TEST CARBON DIOXIDE (CO2) ITEM #67... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K863544 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1986
Decision
17d
Days
Class 2
Risk

K863544 is an FDA 510(k) clearance for the EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 17 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K863544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date September 29, 1986
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
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 K863544.
BICARBONATE
K874435 · Boehringer Mannheim Corp. · Nov 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · Abbott Laboratories · Jun 1987
BICARBONATE PROCEDURE
K870062 · Data Medical Associates, Inc. · Feb 1987
BICARBONATE PROCEDURE
K861673 · Data Medical Associates, Inc. · Jul 1986
RAICHEM CO2 REAGENT
K854544 · Reagents Applications, Inc. · Dec 1985
DATA ZYME CO2 PROCEDURE
K850903 · Data Medical Associates, Inc. · Apr 1985