# K111339: Hemostasis Managment System Plus (HMS-Plus)

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jun 8, 2011 after 27 days
- Product code: JOX (Analyzer, Heparin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894317 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101271: Hemostasis Management System Plus (HMS Plus ), Model 305 XX, Medtronic, Inc. (2010) Summary page 1.

## Indications for use
The HMVS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.

Source page: https://510kreport.com/device/K111339
Methodology: https://510kreport.com/methodology