510(k) · Cleared
ClearedCPS Excel Mediguide Enabled Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Cardiac Rhythm Management Divisi · DQX Wire, Guide, Catheter
Cleared on May 8, 2012 as substantially equivalent to K073082 (Brivant, Ltd., 2008) and 1 other predicate after a 98-day review. Its family tree reaches back 12 generations to 1993. 6 of the 83 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 98 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K926514 (1993). 74 ancestors in all, the oldest K882061 (1988). 8 later devices descend from it, 2 citing it directly. 6 of the 83 devices in this family, counting this one, have 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 deviceK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
- Descendant · cites it directly · 6 of its ownK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK242133 Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK243842 Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · Recalled (Class I)
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 deviceK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…10 generations back · 2003
- K190106 Intra-Operative Positioning System; Simple Curve…cites it directly · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…2 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…2 generations on · 2024
Most influential descendants
Showing 5 of 8 · See all- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc. · 2019 · cites it directly6descendants
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc. · 2023 · 2 generations on5descendants
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc. · 2024 · 2 generations on3descendants
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc. · 2024 · 2 generations on3descendants
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 2 generations on2descendants
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) | K120298 | CPS Excel Mediguide Enabled Guidewire | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | — |
| +1 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve… | Centerline Biomedical, Inc. | 2019 | Class I |
| +2 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter… | Centerline Biomedical, Inc. | 2023 | Class I |
| +2 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)… | Centerline Biomedical, Inc. | 2024 | Class I |
| +2 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | Class I |
| +2 | K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 1 |
| 2023 | 1 | 1 |
| 2024 | 2 | 2 |
| 2025 | 1 | 1 |
| 2026 | 2 | 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.
6 devices in this family have 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? (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 |
|---|---|---|---|
| * | K073082 | CPS Courier GuidewireSummary page 1…1 CFR 870.1330 Catheter, Guidewire DQX The subject device is equivalent to the following St Jude Medical and MediGuide Devices St Jude Medical CPS Courier™ Guidewire (K073082) cleared on January 9, 2008 MediGuide Guided Measurement Catheter (GMC) (K091781) cleared on October 16, 2009 The St. Jude Medi… | 2008 |
| * | K091781 | Guided Medical Positioning System (GMPS)Summary page 1…ollowing St Jude Medical and MediGuide Devices St Jude Medical CPS Courier™ Guidewire (K073082) cleared on January 9, 2008 MediGuide Guided Measurement Catheter (GMC) (K091781) cleared on October 16, 2009 The St. Jude Medical CPS Excel™, MediGuide Enabled™ guidewire is a MediGuide enabled guidewire with… | 2009 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 2 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
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, K190106 (Centerline Biomedical, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K073082.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120298: CPS Excel Mediguide Enabled Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120298
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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