510(k) · Cleared
ClearedCPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQX Wire, Guide, Catheter
Cleared on Nov 13, 2014 as substantially equivalent to K120298 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2012) after a 91-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
- Nov 13, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- DQX
- 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 backK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- This deviceK142254 CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque…St 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 backK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- This deviceK142254 CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque…St 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 | K120298 | CPS Excel Mediguide Enabled Guidewire | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| 0 (this device) | K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS… | 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 | 3 | 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K120298 | CPS Excel Mediguide Enabled GuidewireSummary page 4…have only undergone minimal design changes to connect directly to the MediGuide technology as compared to the predicate, MediGuide Enabled™ Guidewire Connector DS2M032 (K120298). Submitter: St. Jude Medical, CRMD Address: 15900 Valley View Ct… | 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.
- 1 other device also cites its predicate K120298.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142254: CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142254
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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