Cleared Traditional

HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM (K841021) - FDA 510(k) Clearance

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

K841021 · Hemotec, Inc. · Hematology device
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May 1984
Decision
74d
Days
Class 2
Risk

K841021 is an FDA 510(k) clearance for the HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM. 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 May 25, 1984 after a review of 74 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.

View all Hemotec, Inc. devices

Submission Details

510(k) Number K841021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date May 25, 1984
Days to Decision 74 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 113d · This submission: 74d
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 K841021.
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