# K893525: Factor Viii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Medical Diagnostic Technologies, Inc.
- Decided: Jun 23, 1989 after 46 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K034007: Hemosil Factor Viii Deficient Plasma (2004), 2 descendants of its own
- K110237: Hemosil Factor Viii Deficient Plasma (2011), 1 descendant of its own
- K222831: CRYOcheck Factor VIII Deficient Plasma with VWF (2023), 0 descendants of its own
- K990046: Pacific Hemostasis Immunodepleted Factor Viii Deficient Plasma (1999), 0 descendants of its own
- K961929: Factor Deficient Plasma (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K893525
Methodology: https://510kreport.com/methodology