510(k) · Cleared
ClearedRubicon Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · DQY Catheter, Percutaneous
Cleared on Nov 9, 2011 as substantially equivalent to K033678 (Spectranetics Corp., 2004) after a 90-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Nov 9, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935425 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 3 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 2 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 1 generation backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- This deviceK112303 Rubicon Support CatheterBoston Scientific · 2011
- Descendant · cites it directly · 2 of its ownK122394 Rubicon 18 Support CatheterBoston Scientific Corp · 2012
- Descendant · cites it directly · 1 of its ownK171913 Rubicon 14, 18 and 35 Support CathetersBoston Scientific Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK223633 Rubicon™ Control Support Catheter (H749394323506A1)Boston Scientific Corporation · 2023
Most influential descendants
Showing 3 of 3 · See all- K122394Rubicon 18 Support CatheterBoston Scientific Corp · 2012 · cites it directly2descendants
- K171913Rubicon 14, 18 and 35 Support CathetersBoston Scientific Corporation · 2017 · cites it directly1descendant
- K223633Rubicon™ Control Support Catheter (H749394323506A1)Boston Scientific Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −3 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −2 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −1 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| 0 (this device) | K112303 | Rubicon Support Catheter | Boston Scientific | 2011 | — |
| +1 | K122394 | Rubicon 18 Support Catheter | Boston Scientific Corp | 2012 | — |
| +1 | K171913 | Rubicon 14, 18 and 35 Support Catheters | Boston Scientific Corporation | 2017 | — |
| +2 | K223633 | Rubicon™ Control Support Catheter (H749394323506A1) | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 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? (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 |
|---|---|---|---|
| * | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Summary page 1…s Catheter Product Code OQY Classification Class 11, 21 CFR Part 870.1250 Predicate Spectranetics K033678 23 February 2004 Device Quick-Cross Support Catheter Device The Boston Scientific R… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122394 (Boston Scientific Corp, 2012) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K033678.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Rubicon Support Catheter is intended to facilitate placement and
support of guidewires and other interventional devices within the
peripheral vasculature and to allow for exchange of guidewires, and
provide a conduit for the delivery of saline or contrast solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112303: Rubicon Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112303
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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