510(k) · Cleared
ClearedOptiCross™ 18 Peripheral Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · OBJ Catheter, Ultrasound, Intravascular
Cleared on Sep 23, 2022 as substantially equivalent to K160514 (Boston Scientific Corporation, 2016) after a 30-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 23, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970049 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK970049 BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC…Cardiovascular Imaging Systems, Inc. · 1997
- 3 generations backK060947 Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020Boston Scientific Corp · 2006
- 2 generations backK073623 Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp · 2008
- 1 generation backK160514 OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation · 2016
- This deviceK222568 OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath… | Cardiovascular Imaging Systems, Inc. | 1997 | — |
| −3 | K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 | Boston Scientific Corp | 2006 | — |
| −2 | K073623 | Atlantis 018 Peripheral Imaging Catheter | Boston Scientific Corp | 2008 | — |
| −1 | K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2016 | — |
| 0 (this device) | K222568 | OptiCross™ 18 Peripheral Imaging Catheter | Boston Scientific Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K160514 | OptiCross 18, 30 MHz Peripheral Imaging CatheterSummary page 4…CFR 892.1570 Predicate Device OptiCrossTM 18 Peripheral June 22, 2016 K160514 Imaging Catheter OptiCrossTM 35 Peripheral April 17, 2020… | 2016 |
| † | K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | 2020 |
| † | K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | 2022 |
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 25 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 2 of the 6 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. 2022, 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?
OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222568: OptiCross™ 18 Peripheral 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/K222568
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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