# K900411: Factor XI Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Chemical Co.
- Decided: Mar 6, 1990 after 36 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K981173: Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML) (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K900411
Methodology: https://510kreport.com/methodology