Cleared Traditional

HEPCOL SYSTEM B-10 & B-10-P (K830665) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 K830665.
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339 · Medtronic, Inc. · Jun 2011
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · Medtronic, Inc. · Nov 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · Medtronic, Inc. · Oct 2010
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