# K951891: Acl Futura Coagulation System

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 3, 1995 after 193 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- 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; 2 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
- K043184: Hemosil Recombiplastin (2004), 3 descendants of its own
- K070005: Hemosil Recombiplastin 2G (2007), 2 descendants of its own
- K122584: Hemosil Readiplas Tin (2013), 1 descendant of its own
- K213426: HemosIL ReadiPlasTin (2022), 0 descendants of its own
- K973306: IL Test Aptt-SP (1997), 0 descendants of its own

## Recalls of this device
- May 19, 2005 · Not classified · Z-0915-05: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
- Mar 4, 2004 · Not classified · Z-0736-04: Software may cause instrument to omit step causing reagent carrover which may effect patient test result

Source page: https://510kreport.com/device/K951891
Methodology: https://510kreport.com/methodology