Cleared Traditional

K830665 - HEPCOL SYSTEM B-10 & B-10-P

K830665 is an FDA 510(k) clearance for HEPCOL SYSTEM B-10 & B-10-P, 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 97-day FDA review.

K830665 · Hemotec, Inc. · Hematology device
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Jun 1983
Decision
97d
Days
Class 2
Risk

K830665 is an FDA 510(k) clearance for the HEPCOL SYSTEM B-10 & B-10-P. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Hemotec, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hemotec, Inc. devices

FDA 510(k) Submission Details - K830665

510(k) Number K830665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1983
Decision Date June 08, 1983
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
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 8
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K830665.
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080 · Medtronic Vascular · Dec 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070 · Medtronic Vascular · Oct 2004
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
K993519 · Cardiovascular Diagnostics, Inc. · Jan 2000
HEPAQUANT
K813011 · Streck Laboratories, Inc. · Jan 1982