510(k) · Cleared
ClearedST. Jude Medical Epicardial Catheter System
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 May 13, 2009 after a 321-day review. The FDA summary names its predicate without a number. 7 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- May 13, 2009
- Review
- 321 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly. 7 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK081803 ST. Jude Medical Epicardial Catheter SystemSt Jude Medical · 2009
- Descendant · cites it directly · 11 of its ownK151622 St.Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- Descendant · 2 generations on · 6 of its ownK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK242133 Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK241243 Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve…Centerline Biomedical, Inc. · 2024 · Recalled (Class I)
Showing 5 of 12 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 12 · See all- K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical · 2015 · cites it directly11descendants
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc. · 2019 · 2 generations on6descendants
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc. · 2023 · 3 generations on5descendants
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc. · 2024 · 3 generations on3descendants
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081803 | ST. Jude Medical Epicardial Catheter System | St Jude Medical | 2009 | — |
| +1 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology… | St Jude Medical | 2015 | — |
| +2 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve… | Centerline Biomedical, Inc. | 2019 | Class I |
| +3 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter… | Centerline Biomedical, Inc. | 2023 | Class I |
| +3 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad)… | Centerline Biomedical, Inc. | 2024 | Class I |
| +3 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Response Electrophysiology Catheter Named without a submission number | |
| * | — | Agilis NxT Steerable Introducer Named without a submission number |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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, K151622 (St Jude Medical, 2015) has gone furthest, with 11 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. 2009, 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 St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081803 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081803: ST. Jude Medical Epicardial Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081803
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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