# K894317: Hemotec Hepcon HMS Coagulation System &  Access.

- Pathway: 510(k) (Traditional)
- Applicant: Hemotec, Inc.
- Decided: Sep 5, 1989 after 53 days
- Product code: JOX (Analyzer, Heparin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101271: Hemostasis Management System Plus (HMS Plus ), Model 305 XX (2010), 1 descendant of its own
- K043080: Heparin Dose Response Controls, Model 306-20 Por (2004), 1 descendant of its own
- K042206: Purple/Black Heparin Assay Control (2004), 1 descendant of its own
- K042070: Heparin Dose Response Cartridge, Model 304-20 (2004), 1 descendant of its own
- K111339: Hemostasis Managment System Plus (HMS-Plus) (2011), 0 descendants of its own

## Recalls of this device
- Dec 14, 2009 · Not classified · Z-1070-2010: Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that 

Source page: https://510kreport.com/device/K894317
Methodology: https://510kreport.com/methodology