# K043459: Hemosil Factor Xii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 9, 2005 after 56 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
Longest line of descent: 1 generation back to K893534 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K893534: Factor Xii Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000) Summary page 1.

## Most influential descendants
- K180486: HemosIL Factor XII Deficient Plasma (2018), 0 descendants of its own

## Indications for use
HemosfL Factor XI1 Deficient Plasma is human plasma immunodepleted of factor XH and intended for the in vitro diagnostic quantitative determination of factor XH activity in citrated plasma, based on the activated partial thromboplastin time (APIT) assay, on IL Coagulation and ELECTRA Systems.

Source page: https://510kreport.com/device/K043459
Methodology: https://510kreport.com/methodology