510(k) · Cleared
ClearedOptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · OBJ Catheter, Ultrasound, Intravascular
Cleared on Apr 8, 2026 as substantially equivalent to K230453 (Boston Scientific Corporation, 2023) after a 26-day review. Its family tree reaches back 8 generations to 2005.
- Decided
- Apr 8, 2026
- Review
- 26 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K050577 (2005). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK050577 Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp · 2005 · Recalled
- 7 generations backK063312 Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging…Boston Scientific Corp · 2006 · Recalled
- 6 generations backK111043 Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging…Boston Scientific Corp · 2011
- 5 generations backK123621 Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · Recalled
- 4 generations backK153617 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution)…Boston Scientific Corporation · 2016
- 3 generations backK173820 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2018
- 2 generations backK213593 OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation · 2022 · Recalled
- 1 generation backK230453 OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary…Boston Scientific Corporation · 2023
- This deviceK260816 OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6…Boston Scientific · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K050577 | Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 | Boston Scientific Corp | 2005 | 2 |
| −7 | K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model… | Boston Scientific Corp | 2006 | 2 |
| −6 | K111043 | Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter | Boston Scientific Corp | 2011 | — |
| −5 | K123621 | Opticross 40 MHZ Coronary Imaging Catheter | Boston Scientific Corp | 2013 | 1 |
| −4 | K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6… | Boston Scientific Corporation | 2016 | — |
| −3 | K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD… | Boston Scientific Corporation | 2018 | — |
| −2 | K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | 2022 | 1 |
| −1 | K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging… | Boston Scientific Corporation | 2023 | — |
| 0 (this device) | K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging… | Boston Scientific | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterSummary page 5…21 CFR 892.1570 Predicate Device OptiCrossTM HD Coronary Imaging Catheter OptiCrossTM 6 HD Coronary Imaging Catheter K230453 cleared 18-May-2023 Device Description The OptiCross and OptiCross 6 40 MHz Coronary Imaging Catheters are sterile, short rail im… | 2023 |
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 21 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 9 ancestors have a recall of any class.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260816: OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260816
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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