510(k) · Cleared
ClearedLivesire 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 Oct 1, 2002 after a 71-day review. The FDA summary names its predicate without a number. 9 of the 74 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it.
- Decided
- Oct 1, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
73 later devices descend from it, 8 citing it directly. 9 of the 74 devices in this family, counting this one, have a Class I recall.
- This deviceK022380 Livesire Electrophysiology CatheterSt Jude Medical · 2002
- Descendant · cites it directly · 53 of its ownK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- Descendant · 2 generations on · 36 of its ownK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- Descendant · cites it directly · 14 of its ownK102721 Livewire Electophysiology CatheterSt Jude Medical · 2010
- Descendant · cites it directly · 12 of its ownK150631 St. Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- Descendant · cites it directly · 11 of its ownK151622 St.Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 73 · See all- K061363Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · cites it directly53descendants
- K081645Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008 · 2 generations on36descendants
- K102721Livewire Electophysiology CatheterSt Jude Medical · 2010 · cites it directly14descendants
- K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…St Jude Medical · 2015 · cites it directly12descendants
- K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical · 2015 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022380 | Livesire Electrophysiology Catheter | St Jude Medical | 2002 | — |
| +1 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| +2 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| +1 | K102721 | Livewire Electophysiology Catheter | St Jude Medical | 2010 | — |
| +1 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology… | St Jude Medical | 2015 | — |
| +1 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology… | St Jude Medical | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 1 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 1 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 1 |
| 2023 | 7 | 2 |
| 2024 | 10 | 3 |
| 2025 | 5 | 1 |
| 2026 | 8 | 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.
9 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? (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 |
|---|---|---|---|
| * | — | Electrophysiology Catheter Named without a submission number |
What descends from it? (73)
See all 738 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061363 | Agilis NXT Steerable Introducer | 2006 | 53 |
| K102721 | Livewire Electophysiology Catheter | 2010 | 14 |
| K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter… | 2015 | 12 |
| K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter… | 2015 | 11 |
| K160242 | Reprocessed Livewire Steerable Diagnostic EP Catheter | 2016 | 1 |
| K160390 | Map-it Diagnostic Mapping Catheters | 2016 | 1 |
| K151617 | Livewire Electrophysiology Catheter | 2016 | 0 |
| K042074 | Vanguard Reprocessed Diagnostic Electrophysiology Catheters | 2005 | 0 |
Has anything in its family been recalled? (9 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.
- K152090Reprocessed Steerable IntroducerSterilmed, Inc. · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- 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
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- Of its descendants, K061363 (St Jude Medical, 2006) has gone furthest, with 53 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.
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?
SJM-Daig 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/K022380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022380: Livesire Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022380
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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