510(k) · Cleared
Recalled · 2009Hemotec Hepcon HMS Coagulation System & Access.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemotec, Inc. · JOX Analyzer, Heparin, Automated
Cleared on Sep 5, 1989 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled once.
- Decided
- Sep 5, 1989
- Review
- 53 days
- Class
- Class II
- Product code
- JOX
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 5 citing it directly.
- This deviceK894317 Hemotec Hepcon HMS Coagulation System & Access.Hemotec, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK101271 Hemostasis Management System Plus (HMS Plus ), Model 305 XXMedtronic, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK043080 Heparin Dose Response Controls, Model 306-20 PorMedtronic Vascular · 2004
- Descendant · cites it directly · 1 of its ownK042206 Purple/Black Heparin Assay ControlMedtronic Vascular · 2004
- Descendant · cites it directly · 1 of its ownK042070 Heparin Dose Response Cartridge, Model 304-20Medtronic Vascular · 2004
- Descendant · 2 generations on · 0 of its ownK111339 Hemostasis Managment System Plus (HMS-Plus)Medtronic, Inc. · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K101271Hemostasis Management System Plus (HMS Plus ), Model 305 XXMedtronic, Inc. · 2010 · cites it directly1descendant
- K043080Heparin Dose Response Controls, Model 306-20 PorMedtronic Vascular · 2004 · cites it directly1descendant
- K042206Purple/Black Heparin Assay ControlMedtronic Vascular · 2004 · cites it directly1descendant
- K042070Heparin Dose Response Cartridge, Model 304-20Medtronic Vascular · 2004 · cites it directly1descendant
- K111339Hemostasis Managment System Plus (HMS-Plus)Medtronic, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894317 | Hemotec Hepcon HMS Coagulation System & Access. | Hemotec, Inc. | 1989 | — |
| +1 | K101271 | Hemostasis Management System Plus (HMS Plus ), Model 305 XX | Medtronic, Inc. | 2010 | — |
| +1 | K043080 | Heparin Dose Response Controls, Model 306-20 Por | Medtronic Vascular | 2004 | — |
| +1 | K042206 | Purple/Black Heparin Assay Control | Medtronic Vascular | 2004 | — |
| +1 | K042070 | Heparin Dose Response Cartridge, Model 304-20 | Medtronic Vascular | 2004 | — |
| +2 | K111339 | Hemostasis Managment System Plus (HMS-Plus) | Medtronic, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2009 | Not classified | Z-1070-2010 | Other | Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101271 (Medtronic, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOX devicesJOX Analyzer, Heparin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K894317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894317: Hemotec Hepcon HMS Coagulation System & Access..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894317
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026