510(k) · Cleared
ClearedCPS Direct Universal Slittable Outer Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQY Catheter, Percutaneous
Cleared on Mar 20, 2013 as substantially equivalent to K092075 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2009) after a 47-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Mar 20, 2013
- Review
- 47 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092075 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK092075 CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002…St. Jude Medical, Cardiac Rhythm Management Divisi · 2009
- This deviceK130257 CPS Direct Universal Slittable Outer CatheterSt Jude Medical · 2013
- Descendant · cites it directly · 0 of its ownK231311 CPS Direct™ Universal slittable outer guide catheter (DS2C029)Abbott Medical · 2023
Most influential descendants
Showing 1 of 1 · See all- K231311CPS Direct™ Universal slittable outer guide catheter (DS2C029)Abbott Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092075 | CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003… | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009 | — |
| 0 (this device) | K130257 | CPS Direct Universal Slittable Outer Catheter | St Jude Medical | 2013 | — |
| +1 | K231311 | CPS Direct™ Universal slittable outer guide catheter (DS2C029) | Abbott Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092075 | CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004…Summary page 1…ges to the catheter to increase the inner diameter, outer diameter and hub of the catheter as compared to the predicate, CPS Direct® SLII slittable outer catheter (K092075). Submitter: St. Jude Medical, CRMVD Address: 15900 Valley View Ct… | 2009 |
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 |
|---|---|---|---|
| K231311 | CPS Direct™ Universal slittable outer guide catheter (DS2C029) | 2023 | 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?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 St. Jude Medical CPS DirectTM Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct Universal slittable outer guide catheters can work with inner catheters as a system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130257: CPS Direct Universal Slittable Outer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130257
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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