Cleared Traditional

HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES (K884590) - FDA 510(k) Clearance

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

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 45
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K884590.
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COAMATIC HEPARIN
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IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994