510(k) · Cleared
ClearedAdvisor HD Grid Mapping Catheter, Sensor Enabled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Inc. · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Apr 23, 2018 as substantially equivalent to K120425 (Biosense Webster, Inc., 2012) and 1 other predicate after a 258-day review. Its family tree reaches back 5 generations to 1999. 21 later devices descend from it.
- Decided
- Apr 23, 2018
- Review
- 258 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K983171 (1999). 16 ancestors in all, the oldest K961924 (1997). 21 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 4 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 3 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 2 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 1 generation backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- This deviceK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- 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
- Descendant · 4 generations on · 11 of its ownK221213 EnSite X EP SystemAbbott · 2022
- Descendant · 5 generations on · 10 of its ownK223094 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™…Abbott Medical · 2022
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- 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
- K221213EnSite X EP SystemAbbott · 2022 · 4 generations on11descendants
- K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical · 2022 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −4 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −3 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −2 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| −1 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| 0 (this device) | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| +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 | — |
| +4 | K221213 | EnSite X EP System | Abbott | 2022 | — |
| +5 | K223094 | EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software… | Abbott Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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 MTD? 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 MTD device
- #1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.4 · 7 generations · 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 |
|---|---|---|---|
| * | K120425 | Pentaray Nav High-Density Mapping CatheterSummary page 4…Procode MTD; Class II Primary: PentaRay NAV High Density Mapping Catheter, Biosense Webster; K120425 Predicate Device Secondary: Advisor FL Circular Mapping Catheter, Sensor Enabled, St. Jude… | 2012 |
| * | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…Summary page 4…K120425 Predicate Device Secondary: Advisor FL Circular Mapping Catheter, Sensor Enabled, St. Jude Medical; K160335 EnSite™ Velocity™ Cardiac Mapping System v5.2 & EnSite Precision™ Reference Application Cardia… | 2016 |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL… | 2020 | 17 |
| K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | 2024 | 3 |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | 2020 | 1 |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | 2021 | 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 3 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K202066 (Abbott Medical, 2020) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K120425.
How does its category compare?
All MTD devicesMTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MTD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 2025
MAUDE reports naming product code MTD, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 17 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 2 | 38 |
| 2018 | 1 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 77 |
| 2020 | 4 | 169 | 0 | 87 |
| 2021 | 1 | — | 0 | 99 |
| 2022 | 2 | — | 0 | 145 |
| 2023 | 3 | 66 | 0 | 184 |
| 2024 | 2 | — | 0 | 378 |
| 2025 | 0 | — | 0 | 385 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172393
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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