510(k) · Cleared
Recalled · Class II · 2024Opticross 40 MHZ Coronary Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · OBJ Catheter, Ultrasound, Intravascular
Cleared on Apr 15, 2013 as substantially equivalent to K111043 (Boston Scientific Corp, 2011) after a 143-day review. Its family tree reaches back 3 generations to 2005. 8 later devices descend from it. It has been recalled once.
- Decided
- Apr 15, 2013
- Review
- 143 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K050577 (2005). 8 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK050577 Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp · 2005 · Recalled
- 2 generations backK063312 Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging…Boston Scientific Corp · 2006 · Recalled
- 1 generation backK111043 Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging…Boston Scientific Corp · 2011
- This deviceK123621 Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013
- Descendant · cites it directly · 5 of its ownK153617 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution)…Boston Scientific Corporation · 2016
- Descendant · 2 generations on · 3 of its ownK173820 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2018
- Descendant · cites it directly · 3 of its ownK173284 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2017
- Descendant · 2 generations on · 2 of its ownK213593 OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK230453 OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary…Boston Scientific Corporation · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…Boston Scientific Corporation · 2016 · cites it directly5descendants
- K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation · 2018 · 2 generations on3descendants
- K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…Boston Scientific Corporation · 2017 · cites it directly3descendants
- K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation · 2022 · 2 generations on2descendants
- K230453OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterBoston Scientific Corporation · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050577 | Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 | Boston Scientific Corp | 2005 | 2 |
| −2 | K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model… | Boston Scientific Corp | 2006 | 2 |
| −1 | K111043 | Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter | Boston Scientific Corp | 2011 | — |
| 0 (this device) | K123621 | Opticross 40 MHZ Coronary Imaging Catheter | Boston Scientific Corp | 2013 | — |
| +1 | K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6… | Boston Scientific Corporation | 2016 | — |
| +2 | K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD… | Boston Scientific Corporation | 2018 | — |
| +1 | K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60… | Boston Scientific Corporation | 2017 | — |
| +2 | K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | 2022 | 1 |
| +3 | K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging… | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K111043 | Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterSummary page 3…ice design features intended to enhance deliverability, reliability, and overall ease of use when compared to iCroSSTM (K1 11043). Modifications with respect to the predicate device include: a new hub interface with the… | 2011 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2024 | Class II | Z-1396-2024 | Process control | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K153617 (Boston Scientific Corporation, 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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/K123621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123621: Opticross 40 MHZ Coronary Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123621
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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