Cleared Traditional

K891991 - BICARBONATE

Also marketed or referenced as:
SYSTEM PACK REAGENTS

K891991 is an FDA 510(k) clearance for BICARBONATE, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K891991 · Boehringer Mannheim Corp. · Chemistry device
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Jun 1989
Decision
73d
Days
Class 2
Risk

K891991 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 June 9, 1989 after a review of 73 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

FDA 510(k) Submission Details - K891991

510(k) Number K891991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date June 09, 1989
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K891991.
CARBON DIOXIDE REAGENT
K896590 · Pointe Scientific, Inc., · Feb 1990
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
K895748 · Catachem, Inc. · Dec 1989
BICARBONATE TEST ITEM NUMBER: 65412
K894509 · Em Diagnostic Systems, Inc. · Sep 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305 · Em Diagnostic Systems, Inc. · Feb 1989
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · Abbott Laboratories · Dec 1988
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868 · Diagnostic Chemicals, Ltd. (Usa) · Nov 1988