# K042206: Purple/Black Heparin Assay Control

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Oct 18, 2004 after 63 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 K894317 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922031: HMS Purple and Black Heparin Cartridges & Control, Medtronic Hemotec, Inc. (1992) Summary page 1.
- K894317: Hemotec Hepcon HMS Coagulation System &  Access., Hemotec, Inc. (1989) Summary page 1.

## Most influential descendants
- K103313: Heparin Assay Controls (2010), 0 descendants of its own

## Indications for use
To verify the performance of the HMS instrument and HMS Heparin Assay cartridges

Source page: https://510kreport.com/device/K042206
Methodology: https://510kreport.com/methodology