# K862301: IL System 810, Acl and the Reagent Sets

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 3, 1986 after 78 days
- Product code: GJA (Test, Thrombin Time)
- Device class: 2
- Regulation: 21 CFR 864.7875
- 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; 1 cites 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
- K012768: Hemosil Recombi Plastin (2001), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K862301
Methodology: https://510kreport.com/methodology