510(k) · Cleared
ClearedMedline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · PNE Reprocessed Catheter Introducer
Cleared on Dec 19, 2025 as substantially equivalent to K251211 (Abbott Medical, 2025) after a 318-day review. Its family tree reaches back 15 generations to 2000.
- Decided
- Dec 19, 2025
- Review
- 318 days
- Class
- Class II
- Product code
- PNE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K000248 (2000). 71 ancestors in all, the oldest K954395 (1995). No later device cites it as a predicate yet.
- Root · 15 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 11 generations between
- 3 generations backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- 2 generations backK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- 1 generation backK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
- This deviceK250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025
Show all 15 generations
- Root · 15 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 14 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 13 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 12 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 11 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 10 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 9 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 8 generations backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- 7 generations backK160218 AutoMark ModuleSt Jude Medical · 2016
- 6 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 5 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 4 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 3 generations backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- 2 generations backK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- 1 generation backK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
- This deviceK250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −14 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −13 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −12 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −11 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −10 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −9 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −8 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| −7 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| −6 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| −5 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −4 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −3 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
| −2 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| −1 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™… | Abbott Medical | 2025 | — |
| 0 (this device) | 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 |
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 PNE? 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 PNE device
- #1 K250305 Reprocessed Agilis NxT Steerable Introducerscore 14.8 · 15 generations · 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 |
|---|---|---|---|
| * | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… Cleared while this submission was under review Summary page 6…2 Product Code PNE Panel Cardiovascular Predicate The predicate models in K251211 include subject device selection rationale models of this submission. 510(k) Number K… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 71 ancestors have a recall of any class.
- 1 other device also cites its predicate K251211.
How does its category compare?
All PNE devicesPNE Reprocessed Catheter Introducer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PNE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNE
Too few PNE 510(k)s in any year since 2007 to give a median.
Recalls per year · PNE
No recall names PNE since 2007.
Adverse event reports per year · PNE
4in 2024
MAUDE reports naming product code PNE, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medline ReNewal Reprocessed Abbott 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250314: Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250314
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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