Cleared Traditional

K894317 - HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

K894317 is an FDA 510(k) clearance for HEMOTEC HEPCON HMS COAGULATION SYSTEM &..., manufactured by Hemotec, Inc.. The device is a Class 2 Hematology device with product code JOX cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K894317 · Hemotec, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
53d
Days
Class 2
Risk

K894317 is an FDA 510(k) clearance for the HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5680 - 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.

FDA 510(k) Submission Details - K894317

510(k) Number K894317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date September 05, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 113d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOX Device Classification - Class 2, Special Controls

Product Code JOX Analyzer, Heparin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5680
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 - JOX Analyzer, Heparin, Automated

All 14
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K894317.
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
K993519 · Cardiovascular Diagnostics, Inc. · Jan 2000
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
K922031 · Medtronic Hemotec, Inc. · Jul 1992
HEPCON HMS WITH BODY SURFACE AREA CALCULATION
K911240 · Hemotech, Inc. · Jul 1991
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
K854377 · Hemotec, Inc. · Dec 1985
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
K841021 · Hemotec, Inc. · May 1984
HEPCOL SYSTEM B-10 & B-10-P
K830665 · Hemotec, Inc. · Jun 1983
K894317 · HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
Download PDF Hemotec, Inc.