510(k) · Cleared
ClearedRadifocus Optitorque Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Sep 24, 2008 as substantially equivalent to K992051 (Terumo Medical Corp., 1999) after a 6-day review. Its family tree reaches back 3 generations to 1992. 9 later devices descend from it.
- Decided
- Sep 24, 2008
- Review
- 6 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921310 (1992). 6 ancestors in all, the oldest K863137 (1986). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 2 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 1 generation backK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
- This deviceK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
- Descendant · cites it directly · 4 of its ownK150232 Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015
- Descendant · 2 generations on · 3 of its ownK201081 AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020
- Descendant · 3 generations on · 2 of its ownK223918 AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023
- Descendant · cites it directly · 2 of its ownK092372 Heartrail Iii Guiding CatheterTerumo Corp. · 2009
- Descendant · 4 generations on · 1 of its ownK233853 LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015 · cites it directly4descendants
- K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020 · 2 generations on3descendants
- K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023 · 3 generations on2descendants
- K092372Heartrail Iii Guiding CatheterTerumo Corp. · 2009 · cites it directly2descendants
- K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −2 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −1 | K992051 | Radifocus Optitorque | Terumo Medical Corp. | 1999 | — |
| 0 (this device) | K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | 2008 | — |
| +1 | K150232 | Radifocus Optitorque Angiographic Catheter | Ashitaka Factory of Terumo Corp. | 2015 | — |
| +2 | K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | 2020 | — |
| +3 | K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. | 2023 | — |
| +1 | K092372 | Heartrail Iii Guiding Catheter | Terumo Corp. | 2009 | — |
| +4 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K992051 | Radifocus OptitorqueSummary page 1…manual process. E. Design / Materials The Radifocus Optitorque Angiographic Catheter in this submission is the same device that was cleared under K99205 1. There are no changes in the design or materials. Terumo Corporation Premarket Notification - Radifocus® O… | 1999 |
What descends from it? (9)
3 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)
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 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K150232 (Ashitaka Factory of Terumo Corp., 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K992051.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082736: Radifocus Optitorque Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082736
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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