510(k) · Cleared
ClearedAdvisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
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 Dec 13, 2016 as substantially equivalent to K042775 (Irvine Biomedical, Inc., 2004) and 1 other predicate after a 309-day review. Its family tree reaches back 2 generations to 1997. 25 later devices descend from it.
- Decided
- Dec 13, 2016
- Review
- 309 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961924 (1997). 4 ancestors in all. 25 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 1 generation backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
- This deviceK160335 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni…St Jude Medical · 2016
- Descendant · cites it directly · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- Descendant · cites it directly · 18 of its ownK192037 Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019
- Descendant · cites it directly · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- Descendant · 2 generations on · 13 of its ownK212061 EnSite X EP SystemAbbott · 2021
- Descendant · 3 generations on · 12 of its ownK213364 EnSite X EP SystemAbbott Medical · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · cites it directly21descendants
- K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019 · cites it directly18descendants
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · cites it directly17descendants
- K212061EnSite X EP SystemAbbott · 2021 · 2 generations on13descendants
- K213364EnSite X EP SystemAbbott Medical · 2021 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961924 | Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1997 | 2 |
| −1 | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable… | Irvine Biomedical, Inc. | 2004 | — |
| 0 (this device) | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor… | St Jude Medical | 2016 | — |
| +1 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| +1 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | Abbott Medical | 2019 | — |
| +1 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| +2 | K212061 | EnSite X EP System | Abbott | 2021 | — |
| +3 | K213364 | EnSite X EP System | Abbott Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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.
Planning a device in DRF? 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 |
|---|---|---|---|
| * | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterSummary page 4…Advisor FL 20mm 12 Pole 555 Bi D Classification Name: Electrode recording catheter or electrode recording probe Primary Predicate Device: Inquiry AFocus II (K042775) Secondary Predicate MediGuide Enabled Livewire Steerable Electrophysiology Catheter Device: (K101955… | 2004 |
| * | K101955 | ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model…Summary page 4…Predicate Device: Inquiry AFocus II (K042775) Secondary Predicate MediGuide Enabled Livewire Steerable Electrophysiology Catheter Device: (K101955) Device Description: Advisor FL Circular Mapping Catheter, Sensor Enabled (Advisor FL, SE) is… | 2010 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | 2018 | 21 |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | 2019 | 18 |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL… | 2020 | 17 |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | 2020 | 0 |
| K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K172393 (St. Jude Medical, Inc., 2018) has gone furthest, with 21 descendants of its own.
- 10 other devices also cite its predicate K042775.
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. 2016, 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 Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information.
The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160335: Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160335
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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