510(k) · Cleared
ClearedOptiCross 18, 30 MHz 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 Jun 22, 2016 as substantially equivalent to K073623 (Boston Scientific Corp, 2008) after a 119-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Jun 22, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970049 (1997). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK970049 BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC…Cardiovascular Imaging Systems, Inc. · 1997
- 2 generations backK060947 Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020Boston Scientific Corp · 2006
- 1 generation backK073623 Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp · 2008
- This deviceK160514 OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation · 2016
- Descendant · cites it directly · 0 of its ownK222568 OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K222568OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath… | Cardiovascular Imaging Systems, Inc. | 1997 | — |
| −2 | K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 | Boston Scientific Corp | 2006 | — |
| −1 | K073623 | Atlantis 018 Peripheral Imaging Catheter | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K073623 | Atlantis 018 Peripheral Imaging CatheterSummary page 4…as Class II per 21 CFR 892.1570. Predicate Atlantis™ 018 K073623 13-Mar-2008 Device Peripheral Imaging Catheter Reference OptiCross™ 40 MHz… | 2008 |
| † | K123621 | Opticross 40 MHZ Coronary Imaging Catheter | 2013 |
| † | K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 | 2006 |
| † | K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222568 | OptiCross™ 18 Peripheral Imaging Catheter | 2022 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K222568 (Boston Scientific Corporation, 2022) has gone furthest, with 0 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. 2016, 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/K160514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160514: OptiCross 18, 30 MHz 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/K160514
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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