510(k) · Cleared
ClearedHemostasis Managment System Plus (HMS-Plus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · JOX Analyzer, Heparin, Automated
Cleared on Jun 8, 2011 as substantially equivalent to K101271 (Medtronic, Inc., 2010) after a 27-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 8, 2011
- Review
- 27 days
- Class
- Class II
- Product code
- JOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894317 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK894317 Hemotec Hepcon HMS Coagulation System & Access.Hemotec, Inc. · 1989 · Recalled
- 1 generation backK101271 Hemostasis Management System Plus (HMS Plus ), Model 305 XXMedtronic, Inc. · 2010
- This deviceK111339 Hemostasis Managment System Plus (HMS-Plus)Medtronic, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101271 | Hemostasis Management System Plus (HMS Plus ), Model 305 XXSummary page 1…zer Regulation Number: 21 CFR 864.5680 Product Code: JOX Classification: Class 11 Predicate Device HMS Plus (K101271 - Cleared October 13, 2010) Comparison to Predicate Device A comparison of the modified device and the currently marketed HMS… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 21.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JOX devicesJOX Analyzer, Heparin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JOX
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · JOX
Too few JOX 510(k)s in any year since 2007 to give a median.
Recalls per year · JOX
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOX
65in 2025
MAUDE reports naming product code JOX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 0 | — | 0 | 50 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 65 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111339: Hemostasis Managment System Plus (HMS-Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111339
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026