510(k) · Cleared
ClearedSt.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
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 Jul 15, 2015 as substantially equivalent to K101955 (St Jude Medical, 2010) and 10 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1993. 7 of the 23 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Jul 15, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 3 generations to K913940 (1993). 11 ancestors in all, the oldest K894500 (1989). 11 later devices descend from it, 5 citing it directly. 7 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK913940 Response (TM) Steerable CatheterDaig Corp. · 1993
- 2 generations backK102721 Livewire Electophysiology CatheterSt Jude Medical · 2010
- 1 generation backK150631 St. Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- This deviceK151622 St.Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- 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)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241156 Medline ReNewal Reprocessed St. Jude Medical…cites it directly · 2024
- K190106 Intra-Operative Positioning System; Simple Curve…cites it directly · 2019
- K221067 Medline ReNewal Reprocessed St. Jude Medical…cites it directly · 2023
- K242133 Intra-Operative Positioning System (IOPS®)…2 generations on · 2024
Most influential descendants
Showing 5 of 11 · 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 |
|---|---|---|---|---|---|
| −3 | K913940 | Response (TM) Steerable Catheter | Daig Corp. | 1993 | — |
| −2 | K102721 | Livewire Electophysiology Catheter | St Jude Medical | 2010 | — |
| −1 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology… | St Jude Medical | 2015 | — |
| 0 (this device) | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology… | St Jude Medical | 2015 | — |
| +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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 1 |
| 2023 | 2 | 2 |
| 2024 | 3 | 3 |
| 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.
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? (11)
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 |
|---|---|---|---|
| * | K101955 | ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model…Summary page 9…Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K101955, K150631) Device Description: The MediGuide Enabled Livewire Steerable Electrophysiology Catheter i… | 2010 |
| * | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…Summary page 9…Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K101955, K150631) Device Description: The MediGuide Enabled Livewire Steerable Electrophysiology Catheter is designe… | 2015 |
| * | K913940 | Response (TM) Steerable CatheterSummary page 10…or electrode recording probe Class: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Livewire™ Steerable Electrophysiology Catheter (K913940, K022380, K102721, K150631) Device Description: The SJM Livewire™ Steerable Electrophysiology Cathete… | 1993 |
| * | K022380 | Livesire Electrophysiology CatheterSummary page 10…ss: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Livewire™ Steerable Electrophysiology Catheter (K913940, K022380, K102721, K150631) Device Description: The SJM Livewire™ Steerable Electrophysiology Catheter is a fl… | 2002 |
| * | K102721 | Livewire Electophysiology CatheterSummary page 10…Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Livewire™ Steerable Electrophysiology Catheter (K913940, K022380, K102721, K150631) Device Description: The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible el… | 2010 |
| * | K914278 | Daig Electrophysiology Catheter W/Infusion LumenSummary page 11…r electrode recording probe Class: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Response ™ Electrophysiology Catheter with Lumen (K914278, K942379, K120544) Device Description: The Response™ Electrophysiology Catheter with Lumen is a steri… | 1992 |
| * | K942379 | Daig Diagnostic Electrophysiology CatheterSummary page 11…: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Response ™ Electrophysiology Catheter with Lumen (K914278, K942379, K120544) Device Description: The Response™ Electrophysiology Catheter with Lumen is a sterile, singl… | 1994 |
| * | K120544 | Response Electrophysiology Catheters with LumenSummary page 11…Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Response ™ Electrophysiology Catheter with Lumen (K914278, K942379, K120544) Device Description: The Response™ Electrophysiology Catheter with Lumen is a sterile, single use, el… | 2012 |
| * | K894500 | Daig Electrophysiology CatheterSummary page 12…g catheter or electrode recording probe Class: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Response™ Electrophysiology Catheter (K894500, K002976) Device Description: The Response™ Electrophysiology Catheter is a sterile, single use, elec… | 1989 |
| * | K002976 | Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX…Summary page 12…r or electrode recording probe Class: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: Response™ Electrophysiology Catheter (K894500, K002976) Device Description: The Response™ Electrophysiology Catheter is a sterile, single use, electrophysio… | 2000 |
| * | K081803 | ST. Jude Medical Epicardial Catheter SystemSummary page 13…ording catheter or electrode recording probe Class: Class II, 21 CFR 870.1220, Product Code DRF Predicate Device: SJM™ Epicardial Catheter System (K081803) Response™ Electrophysiology Catheter (K894500) Device Description: The SJM™ Epicardial Catheter Syst… | 2009 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter… Class I | 2019 | 6 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter… Class I | 2024 | 0 |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter Class I | 2023 | 0 |
| K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | 2019 | 0 |
| K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | 2019 | 0 |
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 · Cites it directly · ◆ 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 · Cites it directly · ◆ 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 · Cites it directly · ◆ 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 · 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 7; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K190106 (Centerline Biomedical, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K101955.
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. 2015, 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™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. The Livewire™ Steerable Electrophysiology Catheter can be used in…
Read the full statement (164 words)
The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with MediGuide™ Technology to enable real-time tip positioning and navigation.
The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy.
The Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151622: St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151622
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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