510(k) · Cleared
ClearedHeparin Dose Response Controls, Model 306-20 Por
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · JOX Analyzer, Heparin, Automated
Cleared on Dec 3, 2004 as substantially equivalent to K894317 (Hemotec, Inc., 1989) after a 25-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Dec 3, 2004
- Review
- 25 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 deviceK043080 Heparin Dose Response Controls, Model 306-20 PorMedtronic Vascular · 2004
- Descendant · cites it directly · 0 of its ownK051040 Heparin Dose Response Controls, Model 306-20 PorMedtronic Perfusion Systems · 2005
Most influential descendants
Showing 1 of 1 · See all- K051040Heparin Dose Response Controls, Model 306-20 PorMedtronic Perfusion Systems · 2005 · 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) | K043080 | Heparin Dose Response Controls, Model 306-20 Por | Medtronic Vascular | 2004 | — |
| +1 | K051040 | Heparin Dose Response Controls, Model 306-20 Por | Medtronic Perfusion Systems | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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…Heparin Dose Response Control Common Name: Analyzer, Heparin, Automated Classification: Class 11 Predicate Devices: FI-MS Controls K894317 Device Description The HDR Control set is an in vitro diagnostic device. The primary function is to identify if… | 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 |
|---|---|---|---|
| K051040 | Heparin Dose Response Controls, Model 306-20 Por | 2005 | 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.
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 Heparin Dose Response (HDR) controls are used to verify the performance of HDR cartridges and the HMS Plus instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043080: Heparin Dose Response Controls, Model 306-20 Por.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043080
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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