# K101271: Hemostasis Management System Plus (HMS Plus ), Model 305 XX

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 13, 2010 after 160 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: 1 generation back to K894317 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894317: Hemotec Hepcon HMS Coagulation System &  Access., Hemotec, Inc. (1989) Summary page 1.

## Most influential descendants
- K111339: Hemostasis Managment System Plus (HMS-Plus) (2011), 0 descendants of its own

## Indications for use
The HMS 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/K101271
Methodology: https://510kreport.com/methodology