# K042175: Heparinase HR Act Control, Model 550-12

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Oct 18, 2004 after 68 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902081 (1990). 1 ancestor in all.
1 later device descends 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)
- K902081: Clottrac (TM) Ibex Heparinase HR Act Cart./Control, Hemotec, Inc. (1990) Summary page 1.

## Most influential descendants
- K103314: Clotrac Heparinase Test Cartidge (HTC) Coagulation Control (2010), 0 descendants of its own

## Indications for use
To verify the performance of the ACT instrument and the Heparinase (HR HTC) cartridges

Source page: https://510kreport.com/device/K042175
Methodology: https://510kreport.com/methodology