# K902081: Clottrac (TM) Ibex Heparinase HR Act Cart./Control

- Pathway: 510(k) (Traditional)
- Applicant: Hemotec, Inc.
- Decided: Jul 3, 1990 after 56 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K042175: Heparinase HR Act Control, Model 550-12 (2004), 1 descendant of its own
- K103314: Clotrac Heparinase Test Cartidge (HTC) Coagulation Control (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K902081
Methodology: https://510kreport.com/methodology