510(k) · Cleared
ClearedST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model D402058
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Oct 15, 2010 after a 95-day review. The FDA summary names its predicate without a number. 7 of the 40 devices in its family, counting itself, have a Class I recall. 39 later devices descend from it.
- Decided
- Oct 15, 2010
- Review
- 95 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 3 citing it directly. 7 of the 40 devices in this family, counting this one, have a Class I recall.
- This deviceK101955 ST Jude Medical Mediguide Enabled Livewire Steerable…St Jude Medical · 2010
- Descendant · cites it directly · 25 of its ownK160335 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni…St Jude Medical · 2016
- Descendant · 2 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- Descendant · 2 generations on · 18 of its ownK192037 Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019
- Descendant · 2 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- Descendant · 3 generations on · 13 of its ownK212061 EnSite X EP SystemAbbott · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241156 Medline ReNewal Reprocessed St. Jude Medical…2 generations on · 2024
- K190106 Intra-Operative Positioning System; Simple Curve…2 generations on · 2019
- K221067 Medline ReNewal Reprocessed St. Jude Medical…2 generations on · 2023
- K242133 Intra-Operative Positioning System (IOPS®)…3 generations on · 2024
Most influential descendants
Showing 5 of 39 · See all- K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…St Jude Medical · 2016 · cites it directly25descendants
- K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 2 generations on21descendants
- K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019 · 2 generations on18descendants
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 2 generations on17descendants
- K212061EnSite X EP SystemAbbott · 2021 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101955 | ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology… | St Jude Medical | 2010 | — |
| +1 | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor… | St Jude Medical | 2016 | — |
| +2 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| +2 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | Abbott Medical | 2019 | — |
| +2 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| +3 | K212061 | EnSite X EP System | Abbott | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 1 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 2 |
| 2024 | 5 | 3 |
| 2025 | 7 | 1 |
| 2026 | 7 | 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.
7 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · 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 |
|---|---|---|---|
| * | — | St. Jude Medical Livewire Electrophysiology Catheter Named without a submission number | |
| * | — | MediGuide Guided Measurement Catheter (GMC) Named without a submission number |
What descends from it? (39)
See all 393 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12… | 2016 | 25 |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter… | 2015 | 12 |
| K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter… | 2015 | 11 |
Has anything in its family been recalled? (7 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.
- K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology…Surgical Instrument Service and Savings, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 3 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 · 3 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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K160335 (St Jude Medical, 2016) has gone furthest, with 25 descendants of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SJM MediGuide Enabled Livewire TM steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The MediGuide Enabled Livewire TM Steerable Electrophysiology Catheter is used with a compatible gMPSTM system to enable real-time tip positioning and navigation.
The MediGuide System is indicated for use as an adjunct to fluoroscopy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101955: ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model D402058.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101955
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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