# K994100: Pacific Hemostasis Thromboplastin D

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Feb 18, 2000 after 77 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901325 (1990). 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)
- K901325: Thromboplastin.C Plus, Baxter Healthcare Corp (1990) Summary page 1.

## 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

## Recalls of this device
- Mar 6, 2025 · Class II · Z-1503-2025: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Mar 6, 2025 · Class II · Z-1502-2025: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

## Indications for use
Pacific Hemostasis Thromboplastin D is intended for use for performing the one-stage Prothrombin Time test (PT) and PT-based factor assays.

Source page: https://510kreport.com/device/K994100
Methodology: https://510kreport.com/methodology