Cleared Traditional

K884590 - HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN...

K884590 is the FDA 510(k) clearance for HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN... by Hemotec, Inc.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K884590 · Hemotec, Inc. · Hematology device
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Jan 1989
Decision
68d
Days
Class 2
Risk

K884590 is an FDA 510(k) clearance for the HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on January 10, 1989 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - the FDA hematology device 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 Hemotec, Inc. devices

Submission Details

510(k) Number K884590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date January 10, 1989
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 113d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 Hematology devices follow this clearance model.

Regulatory Peers - KFF Assay, Heparin

All 29
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K884590.
HEPARIN CONTROLS, HIGH AND LOW
K910741 · Sigma Diagnostics, Inc. · Apr 1991
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · Organon Teknika Corp. · Oct 1990
ORTHOKROME* HEPARIN
K900396 · Ortho Diagnostic Systems, Inc. · Mar 1990
IL TEST 97575-15, HEPARIN ASSAY
K864211 · Instrumentation Laboratory CO · Jan 1987
HEPANORM CALIBRATION PLASMA SET
K854762 · American Bioproducts Co. · Mar 1986
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · Warner-Lambert Co. · May 1985