# K000679: Thrombostrate Control Plasmas

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Mar 24, 2000 after 24 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021022: Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed) (2002), 2 descendants of its own
- K082859: Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed (2008), 1 descendant of its own
- K110432: Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K000679
Methodology: https://510kreport.com/methodology