# K820450: Thromboscreen

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Mar 26, 1982 after 36 days
- Product code: GIT (Reagent & Control, Partial Thromboplastin Time)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K964963: Lyphochek Coagulation Control (1997), 3 descendants of its own
- K990858: Lypochek Coagulation Control, Model Nos. 787, 788, 789 (1999), 2 descendants of its own
- K012722: Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783 (2001), 1 descendant of its own
- K032611: Lyphochek Coagulation Control, Level 4, Model 743 (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K820450
Methodology: https://510kreport.com/methodology