510(k) · Cleared
ClearedCPS Direct MediGuide Enabled 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 Dec 18, 2014 as substantially equivalent to K120296 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2012) after a 127-day review. Its family tree reaches back 13 generations to 1993. 1 of the 76 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 18, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K926514 (1993). 75 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 76 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 9 generations between
- 3 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 2 generations backK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- 1 generation backK120296 CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- This deviceK142239 CPS Direct MediGuide Enabled outer catheterSt Jude Medical · 2014
Show all 13 generations
- Root · 13 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 12 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 11 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 10 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 9 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 8 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 7 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 6 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 5 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 4 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 3 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 2 generations backK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- 1 generation backK120296 CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- This deviceK142239 CPS Direct MediGuide Enabled outer catheterSt Jude Medical · 2014
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…11 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −12 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −11 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −10 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −9 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −8 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −7 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −6 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −5 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −4 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −3 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −2 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
| −1 | K120296 | CPS Direct Mediguide Enabled Outer Catheter | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| 0 (this device) | K142239 | CPS Direct MediGuide Enabled outer catheter | St Jude Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 1 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K120296 | CPS Direct Mediguide Enabled Outer CatheterSummary page 4…and MediGuide™ Devices St Jude Medical CPS Direct™, MediGuide Enabled™ Slittable Outer Guide Catheter (K120296 cleared on May 11, 2012) Device Description: The St. Jude Medical CPS Direct™, MediGuide Enabled™ outer catheter… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 11 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 17 of the 75 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Direct™, MediGuide Enabled™ 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. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter…
Read the full statement (114 words)
The St. Jude Medical™ CPS Direct™, MediGuide Enabled™ 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. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter are used with the MediGuide System to enable real-time tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, MediGuide Enabled™ 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/K142239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142239: CPS Direct MediGuide Enabled outer catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142239
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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