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 Perfusion Systems · JOX Analyzer, Heparin, Automated
Cleared on May 24, 2005 as substantially equivalent to K043080 (Medtronic Vascular, 2004) after a 29-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- May 24, 2005
- Review
- 29 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 backK043080 Heparin Dose Response Controls, Model 306-20 PorMedtronic Vascular · 2004
- This deviceK051040 Heparin Dose Response Controls, Model 306-20 PorMedtronic Perfusion Systems · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894317 | Hemotec Hepcon HMS Coagulation System & Access. | Hemotec, Inc. | 1989 | 1 |
| −1 | K043080 | Heparin Dose Response Controls, Model 306-20 Por | Medtronic Vascular | 2004 | — |
| 0 (this device) | K051040 | Heparin Dose Response Controls, Model 306-20 Por | Medtronic Perfusion Systems | 2005 | — |
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 |
|---|---|---|---|
| * | K043080 | Heparin Dose Response Controls, Model 306-20 PorSummary page 1…sponse Control Common Name: Analyzer, Heparin, Automated Classification: Class II Predicate Devices: Heparin Dose Response Controls K043080 Device Description The HDR Control set is an in vitro diagnostic device. The primary function is to identify if… | 2004 |
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 16 years and passes through 3 companies; a new generation was cleared every 15.2 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.
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/K051040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051040: 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 4, 2026. https://510kreport.com/device/K051040
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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