510(k) · Cleared
ClearedAtlantis 018 Peripheral Imaging Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Mar 13, 2008 as substantially equivalent to K063312 (Boston Scientific Corp, 2006) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970049 (1997). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970049 BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC…Cardiovascular Imaging Systems, Inc. · 1997
- 1 generation backK060947 Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020Boston Scientific Corp · 2006
- This deviceK073623 Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp · 2008
- Descendant · cites it directly · 1 of its ownK160514 OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK222568 OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath… | Cardiovascular Imaging Systems, Inc. | 1997 | — |
| −1 | K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 | Boston Scientific Corp | 2006 | — |
| 0 (this device) | K073623 | Atlantis 018 Peripheral Imaging Catheter | Boston Scientific Corp | 2008 | — |
| +1 | K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and…Summary page 2…o the following devices: Product 5i0(k) Clearance Date AtlantisTM SR Pro Coronary Imaging K063312 November 30, 2006 Catheter Sonicath UltraiM Imaging Catheter K060947 April 19,… | 2006 |
| * | K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020Summary page 2…earance Date AtlantisTM SR Pro Coronary Imaging K063312 November 30, 2006 Catheter Sonicath UltraiM Imaging Catheter K060947 April 19, 2006 (3.2F) Description of the Device The AtlantisTM 018 Peripheral Imaging Catheter… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | 2016 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K160514 (Boston Scientific Corporation, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K063312.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The AtlantisTM 018 Peripheral Imaging Catheter 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/K073623 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073623: Atlantis 018 Peripheral Imaging Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073623
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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