510(k) · Cleared
ClearedDualView Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corporation · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 17, 2025 as substantially equivalent to K141769 (Lightlab Imaging, Inc., 2014) and 1 other predicate after a 127-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jul 17, 2025
- Review
- 127 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K050577 (2005). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK050577 Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp · 2005 · Recalled
- 3 generations backK063312 Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging…Boston Scientific Corp · 2006 · Recalled
- 2 generations backK111043 Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging…Boston Scientific Corp · 2011
- 1 generation backK123621 Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · Recalled
- This deviceK250751 DualView CatheterTerumo Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050577 | Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 | Boston Scientific Corp | 2005 | 2 |
| −3 | K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model… | Boston Scientific Corp | 2006 | 2 |
| −2 | K111043 | Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter | Boston Scientific Corp | 2011 | — |
| −1 | K123621 | Opticross 40 MHZ Coronary Imaging Catheter | Boston Scientific Corp | 2013 | 1 |
| 0 (this device) | K250751 | DualView Catheter | Terumo Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K141769 | Optis Integrated System, Dragonfly Optis Imaging CatheterSummary page 6…Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed devices to which substantial equivalence is claimed are: Primary Predicate K141769 Optis Integrated System, Dragonfly Optis Imaging Catheter Secondary… | 2014 |
| * | K123621 | Opticross 40 MHZ Coronary Imaging CatheterSummary page 6…redicate K141769 Optis Integrated System, Dragonfly Optis Imaging Catheter Secondary Predicate K123621 Opticross 40 MHz Coronary Imaging Catheter D. REASON FOR 510(k) SUBMISSION This traditional 510(k) for DualView C… | 2013 |
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 20 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141769.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
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/K250751 · printed Nov 3, 2026
Cite this page
510(k) Report. “K250751: DualView Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K250751
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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