Cleared Traditional

K874941 - BIOTROL BICARBONATE (CO2) UV HP)

K874941 is the FDA 510(k) clearance for BIOTROL BICARBONATE (CO2) UV HP) by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K874941 · Biotrol, USA, Inc. · Chemistry device
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Jan 1988
Decision
34d
Days
Class 2
Risk

K874941 is an FDA 510(k) clearance for the BIOTROL BICARBONATE (CO2) UV HP). Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Malvern, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 34 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K874941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date January 05, 1988
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K874941.
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
K880609 · Technicon Instruments Corp. · Mar 1988
CO2 REAGENT
K880268 · Sigma Diagnostics, Inc. · Mar 1988
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