Cleared Traditional

K800161 - HEPCON/SYSTEM RC-10

K800161 is the FDA 510(k) clearance for HEPCON/SYSTEM RC-10 by Hemotec, Inc.. It is a Class 2 Hematology device (product code JOX) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K800161 · Hemotec, Inc. · Hematology device
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Mar 1980
Decision
55d
Days
Class 2
Risk

K800161 is an FDA 510(k) clearance for the HEPCON/SYSTEM RC-10. 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 March 19, 1980 after a review of 55 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 K800161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1980
Decision Date March 19, 1980
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
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.