510(k) · Cleared
ClearedHemostasis Management System Plus (HMS Plus ), Model 305 XX
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 Oct 13, 2010 as substantially equivalent to K894317 (Hemotec, Inc., 1989) after a 160-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Oct 13, 2010
- Review
- 160 days
- Class
- Class II
- Product code
- JOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894317 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK894317 Hemotec Hepcon HMS Coagulation System & Access.Hemotec, Inc. · 1989 · Recalled
- This deviceK101271 Hemostasis Management System Plus (HMS Plus ), Model 305 XXMedtronic, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK111339 Hemostasis Managment System Plus (HMS-Plus)Medtronic, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111339Hemostasis Managment System Plus (HMS-Plus)Medtronic, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894317 | Hemotec Hepcon HMS Coagulation System & Access. | Hemotec, Inc. | 1989 | 1 |
| 0 (this device) | K101271 | Hemostasis Management System Plus (HMS Plus ), Model 305 XX | Medtronic, Inc. | 2010 | — |
| +1 | K111339 | Hemostasis Managment System Plus (HMS-Plus) | Medtronic, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 |
|---|---|---|---|
| * | K894317 | Hemotec Hepcon HMS Coagulation System & Access.Summary page 1…utomated Heparin Analyzer Regulation Number: 21 CFR 864.5680 Product Code: JOX Classification: Class II Predicate Device HMS Pius (K894317/A3) Comparison to Predicate Device A comparison of the modified device and the currently marketed HMS Plus show the following s… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111339 | Hemostasis Managment System Plus (HMS-Plus) | 2011 | 0 |
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?
How does its category compare?
All JOX devicesJOX Analyzer, Heparin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101271: Hemostasis Management System Plus (HMS Plus ), Model 305 XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101271
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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