510(k) · Cleared
ClearedViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · OBJ Catheter, Ultrasound, Intravascular
Cleared on May 23, 2025 as substantially equivalent to K223077 (Irvine Biomedical, A St. Jude Medical Company, 2022) and 5 other predicates after a 35-day review. Its family tree reaches back 14 generations to 2000. 2 later devices descend from it.
- Decided
- May 23, 2025
- Review
- 35 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K000248 (2000). 70 ancestors in all, the oldest K954395 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 10 generations between
- 3 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 2 generations backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- 1 generation backK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- This deviceK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
- Descendant · cites it directly · 0 of its ownK250305 Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026
- Descendant · cites it directly · 0 of its ownK250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 13 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 12 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 11 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 10 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 9 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 8 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 7 generations backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- 6 generations backK160218 AutoMark ModuleSt Jude Medical · 2016
- 5 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 4 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 3 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 2 generations backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- 1 generation backK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- This deviceK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −13 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −12 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −11 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −10 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −9 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −8 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −7 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| −6 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| −5 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| −4 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −3 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −2 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
| −1 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| 0 (this device) | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™… | Abbott Medical | 2025 | — |
| +1 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | — |
| +1 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 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 OBJ? 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K223077 | ViewFlex Xtra ICE CatheterSummary page 6…Classification Name 21 CFR 870.1200, Diagnostic Intravascular Catheter Product Code OBJ Predicate Device ViewFlex™ Xtra ICE Catheter (K223077) Device Description The ViewFlex™ Xtra ICE catheter is a temporary intracardiac ultrasound… | 2022 |
| * | K231588 | ViewFlex™ Eco Reprocessed ICE CatheterSummary page 7…ion Name 21 CFR 870.1200, Diagnostic Intravascular Catheter Product Code OWQ Predicate Device ViewFlex™ Eco Reprocessed ICE Catheter (K231588) Device Description The ViewFlex™ Eco Reprocessed ICE Catheter is a temporary intracardi… | 2023 |
| * | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Summary page 7…ectrode recording probe Product Code MTD Predicate Device Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K202066) K251211 Page 2 of 5 Special 51… | 2020 |
| * | K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™Summary page 8…trode recording probe Product Code MTD Predicate Device Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K241372) Device Description The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (Grid X), i… | 2024 |
| * | K061363 | Agilis NXT Steerable IntroducerSummary page 9…I Classification Name 21 CFR 870.1340 Introducer, Catheter Product Code DYB Predicate Device Agilis™ NxT Steerable Introducer (K061363) Device Description The Agilis™ NxT Steerable Introducer consists of a dilator, guidewire,… | 2006 |
| * | K243493 | Agilis NxT Steerable Introducer Dual-ReachSummary page 9…fication Name 21 CFR 870.1340 Introducer, Catheter Product Code DYB Predicate Device Agilis™ NxT Steerable Introducer Dual‑Reach™ (K243493) K251211 Page 4 of 5 Special 5… | 2024 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 70 ancestors have a recall of any class.
- Of its descendants, K250305 (Innovative Health, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K223077.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac, structures, blood flow and other devices within the heart. The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart. The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ is indicated for multiple electrode…
Read the full statement (200 words)
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac, structures, blood flow and other devices within the heart.
The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
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.
The Advisor™ HD Grid X 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.
The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251211: ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251211
Report an extraction error
Are you the manufacturer?
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