510(k) · Decided
Recalled · Class II · 2018DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 19, 2016 as substantially equivalent to K082736 (Terumo Medical Corp., 2008) after a 102-day review. Its family tree reaches back 4 generations to 1992. It has been recalled 2 times.
- Decided
- Aug 19, 2016
- Review
- 102 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921310 (1992). 7 ancestors in all, the oldest K863137 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 3 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 2 generations backK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
- 1 generation backK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
- This deviceK161287 DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak…Medtronic Vascular · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −3 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −2 | K992051 | Radifocus Optitorque | Terumo Medical Corp. | 1999 | — |
| −1 | K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | 2008 | — |
| 0 (this device) | K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA… | Medtronic Vascular | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 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 DQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K082736 | Radifocus Optitorque Angiographic CatheterSummary page 4…Manufacturer 510(k) clearance # Radifocus Optitorque Terumo Medical K082736 Angiographic Catheter Corporation Device Medtronic’s DxTerity™ Catheters are specialize… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2018 | Class III | Z-3253-2018 | Error in labeling | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has… |
| Mar 13, 2018 | Class II | Z-1479-2018 | Packaging | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K082736.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The diagnostic catheter is indicated for cardiac and vascular procedures. It is designed to deliver radiopaque media, guidewires, and therapeutic agents to selected sites in the vascular system. The different configurations of the diagnostic catheter are designed to be used in arteries from access sites such as the radial, brachial, and femoral arteries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161287: DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161287
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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