# K010750: Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560

- Pathway: 510(k) (Traditional)
- Applicant: Fisher Diagnostics
- Decided: Sep 7, 2001 after 178 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.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090563: Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) (2009), 1 descendant of its own
- K093848: PT-Multi-Calibrator, Model OPAT07 (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K010750
Methodology: https://510kreport.com/methodology