Cleared Traditional

K955302 - SERUM BICARBONATE/CARBON DIOXIDE

K955302 is the FDA 510(k) clearance for SERUM BICARBONATE/CARBON DIOXIDE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K955302 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
101d
Days
Class 2
Risk

K955302 is an FDA 510(k) clearance for the SERUM BICARBONATE/CARBON DIOXIDE. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 101 days - within the typical 510(k) review window.

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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K955302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date February 29, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K955302.
CO2
K981840 · Abbott Laboratories · Jun 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · Roche Diagnostic Systems, Inc. · Jun 1998
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · Synermed, Inc. · Mar 1996
TOTAL CO2
K951221 · Randox Laboratories, Ltd. · Feb 1996
CARBON DIOXIDE (C02)
K942735 · Teco Diagnostics · Mar 1995
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994