510(k) · Cleared
ClearedAtlantis SR Plus Coronary Imaging Catheter, Model 35975
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 29, 2001 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Mar 29, 2001
- Review
- 20 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK010707 Atlantis SR Plus Coronary Imaging Catheter, Model 35975Boston Scientific, Target · 2001
- Descendant · cites it directly · 11 of its ownK093857 C7 XR Imaging System with C7 Dragonfly Imaging Catheter and…Lightlab Imaging, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK152275 Pantheris SystemAvinger, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016
- Descendant · 5 generations on · 4 of its ownK160827 Pantheris CatheterAvinger, Inc. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K093857C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable AccessoriesLightlab Imaging, Inc. · 2010 · cites it directly11descendants
- K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · 2 generations on7descendants
- K152275Pantheris SystemAvinger, Inc. · 2015 · 3 generations on6descendants
- K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016 · 4 generations on5descendants
- K160827Pantheris CatheterAvinger, Inc. · 2016 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010707 | Atlantis SR Plus Coronary Imaging Catheter, Model 35975 | Boston Scientific, Target | 2001 | — |
| +1 | K093857 | C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable… | Lightlab Imaging, Inc. | 2010 | — |
| +2 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
| +3 | K152275 | Pantheris System | Avinger, Inc. | 2015 | — |
| +4 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016 | — |
| +5 | K160827 | Pantheris Catheter | Avinger, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093857 | C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories | 2010 | 11 |
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?
- Of its descendants, K093857 (Lightlab Imaging, Inc., 2010) has gone furthest, with 11 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) | — |
https://510kreport.com/device/K010707 · printed Nov 3, 2026
Cite this page
510(k) Report. “K010707: Atlantis SR Plus Coronary Imaging Catheter, Model 35975.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010707
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026