510(k) · Cleared
Recalled · 2011Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 30, 2005 after a 23-day review. The FDA summary names its predicate without a number. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 30, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 2
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK050577 Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Boston Scientific Corp · 2005
- Descendant · cites it directly · 13 of its ownK063312 Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging…Boston Scientific Corp · 2006 · Recalled
- Descendant · 2 generations on · 9 of its ownK111043 Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging…Boston Scientific Corp · 2011
- Descendant · 3 generations on · 8 of its ownK123621 Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · Recalled
- Descendant · 4 generations on · 5 of its ownK153617 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution)…Boston Scientific Corporation · 2016
- Descendant · 5 generations on · 3 of its ownK173820 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU)…Boston Scientific Corporation · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K063312Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and…Boston Scientific Corp · 2006 · cites it directly13descendants
- K111043Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterBoston Scientific Corp · 2011 · 2 generations on9descendants
- K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp · 2013 · 3 generations on8descendants
- K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…Boston Scientific Corporation · 2016 · 4 generations on5descendants
- K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation · 2018 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050577 | Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014 | Boston Scientific Corp | 2005 | — |
| +1 | K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model… | Boston Scientific Corp | 2006 | 2 |
| +2 | K111043 | Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter | Boston Scientific Corp | 2011 | — |
| +3 | 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 | — |
| +5 | K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD… | Boston Scientific Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | — | BSS Atlantis SR Plus Coronary Imaging Catheter Named without a submission number |
What descends from it? (17)
See all 174 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and… | 2006 | 13 |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 | 2008 | 1 |
| K093993 | Lipiscan Ivus Imaging System Model Nirs-MC7-70 | 2010 | 0 |
| K060175 | Isight Imaging Catheter, Model 38986 | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2011 | Not classified | Z-2418-2011 | Process design | Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have… |
| Mar 28, 2011 | Not classified | Z-2419-2011 | Process design | Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063312 (Boston Scientific Corp, 2006) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Atlantis SR Pro2 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/K050577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050577: Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050577
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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