# K940082: Thromboscreen Thromboplastin-DS

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Feb 14, 1995 after 403 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (0 Class I)
- 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; 3 cite 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
- K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low (2007), 0 descendants of its own
- K040296: Phosphoplastin RL (2004), 0 descendants of its own
- K012410: Infinity Hba Kit, Models 537-a, 537-B (2001), 0 descendants of its own

## Recalls of this device
- Oct 6, 2010 · Not classified · Z-1519-2011: An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.

Source page: https://510kreport.com/device/K940082
Methodology: https://510kreport.com/methodology