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, Cardiac Rhythm Management Divisi · DQY Catheter, Percutaneous
Cleared on May 11, 2012 as substantially equivalent to K092075 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2009) and 1 other predicate after a 101-day review. Its family tree reaches back 12 generations to 1993. 1 of the 76 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 11, 2012
- Review
- 101 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K926514 (1993). 74 ancestors in all, the oldest K882061 (1988). 1 later device descends from it, 1 citing it directly. 1 of the 76 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 8 generations between
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 1 generation backK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- This deviceK120296 CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- Descendant · cites it directly · 0 of its ownK142239 CPS Direct MediGuide Enabled outer catheterSt Jude Medical · 2014
Show all 12 generations
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 10 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 9 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 8 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 7 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 6 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 5 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 4 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 1 generation backK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- This deviceK120296 CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…10 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −11 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −10 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −9 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −8 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −7 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −6 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −5 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −4 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −3 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −1 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
| 0 (this device) | K120296 | CPS Direct Mediguide Enabled Outer Catheter | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (2)
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…uivalent to the following St Jude Medical and MediGuide Devices St Jude Medical CPS DirectTM SL II Slittable Outer Catheter (K092075 cleared on August 7, 2009) MediGuide Guided Measurement Catheter (GMC) (K091781 clea… | 2009 |
| * | K091781 | Guided Medical Positioning System (GMPS)Summary page 1…CPS DirectTM SL II Slittable Outer Catheter (K092075 cleared on August 7, 2009) MediGuide Guided Measurement Catheter (GMC) (K091781 cleared on October 16, 2009) Device Description: The St. Jude Medical CPS Direct MediGuide Enabled slitt… | 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 |
|---|---|---|---|
| K142239 | CPS Direct MediGuide Enabled outer catheter | 2014 | 0 |
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 · 10 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 17 of the 74 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K142239 (St Jude Medical, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092075.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 are…
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/K120296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120296: 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/K120296
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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