# K940401: JR. Microcoagulation System

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: May 11, 1994 after 104 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 3 (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; 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974799: Hemochron JR Generation II, Hemochron JR Signature (1998), 4 descendants of its own
- K020798: Hemochron JR. Signature + (2002), 3 descendants of its own
- K050016: Hemochron Signature Elite (2005), 2 descendants of its own
- K193041: Hemochron Signature Elite (2019), 1 descendant of its own
- K202101: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 (2021), 0 descendants of its own

## Recalls of this device
- Sep 14, 2026 · Not classified · Z-0317-2027: Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high res
- Apr 22, 2016 · Class II · Z-1720-2016: Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
- Jun 20, 2014 · Class II · Z-2088-2014: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

Source page: https://510kreport.com/device/K940401
Methodology: https://510kreport.com/methodology