Cleared Traditional

K955302 - SERUM BICARBONATE/CARBON DIOXIDE

K955302 is an FDA 510(k) clearance for SERUM BICARBONATE/CARBON DIOXIDE, manufactured by Data Medical Associates, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K955302

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.

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 K955302.
CO2
K981231 · Abbott Mfg., Inc. · May 1998
CARBON DIOXIDE - DST
K960035 · Trace America, Inc. · Apr 1996
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · Synermed, Inc. · Mar 1996
TOTAL CO2
K951221 · Randox Laboratories, Ltd. · Feb 1996
CARBON DIOXIDE - DST
K952410 · Trace America, Inc. · Oct 1995
CARBON DIOXIDE (C02)
K942735 · Teco Diagnostics · Mar 1995