Cleared Traditional

K895666 - BUN (KINETIC)

K895666 is an FDA 510(k) clearance for BUN (KINETIC), manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K895666 · Boehringer Mannheim Corp. · Chemistry device
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Oct 1989
Decision
37d
Days
Class 2
Risk

K895666 is an FDA 510(k) clearance for the BUN (KINETIC). Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 - K895666

510(k) Number K895666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date October 27, 1989
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 90
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K895666.
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · Technicon Instruments Corp. · May 1990
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · American Research Products Co. · Apr 1990
DART UREA NITROGEN
K894836 · Coulter Electronics, Inc. · Oct 1989
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
K894173 · Catachem, Inc. · Sep 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · Em Diagnostic Systems, Inc. · Aug 1989
ENZYMATIC UREA NITROGEN REAGENT SET
K892331 · American Monitor Corp. · Jun 1989