Cleared Traditional

BICARBONATE (K874435) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874435 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1987
Decision
26d
Days
Class 2
Risk

K874435 is an FDA 510(k) clearance for the BICARBONATE. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 26 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K874435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date November 23, 1987
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 29
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K874435.
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · Abbott Laboratories · Dec 1988
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
K880609 · Technicon Instruments Corp. · Mar 1988
CO2 REAGENT
K880268 · Sigma Diagnostics, Inc. · Mar 1988
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · Abbott Laboratories · Jun 1987
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · Em Diagnostic Systems, Inc. · Sep 1986
ROCHE REAGENTS REAGENT FOR CO2
K844987 · Roche Diagnostic Systems, Inc. · Jan 1985