# K043080: Heparin Dose Response Controls, Model 306-20 Por

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Dec 3, 2004 after 25 days
- Product code: JOX (Analyzer, Heparin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5680
- 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). 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)
- K894317: Hemotec Hepcon HMS Coagulation System &  Access., Hemotec, Inc. (1989) Summary page 1.

## Most influential descendants
- K051040: Heparin Dose Response Controls, Model 306-20 Por (2005), 0 descendants of its own

## Indications for use
The Heparin Dose Response (HDR) controls are used to verify the performance of HDR cartridges and the HMS Plus instrument.

Source page: https://510kreport.com/device/K043080
Methodology: https://510kreport.com/methodology