510(k) · Cleared
ClearedAgilis NxT Steerable Introducer Dual-Reach
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DYB Introducer, Catheter
Cleared on Dec 13, 2024 as substantially equivalent to K241370 (Abbott Medical, 2024) after a 31-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 13, 2024
- Review
- 31 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964518 (1997). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 3 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 2 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
- 1 generation backK241370 Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)Abbott Medical · 2024
- This deviceK243493 Agilis NxT Steerable Introducer Dual-ReachAbbott Medical · 2024
- Descendant · cites it directly · 2 of its ownK251211 ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter…Abbott Medical · 2025
- Descendant · 2 generations on · 0 of its ownK250305 Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026
- Descendant · 2 generations on · 0 of its ownK250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical · 2025 · cites it directly2descendants
- K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health · 2026 · 2 generations on0descendants
- K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −3 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −2 | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | 1 |
| −1 | K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | Abbott Medical | 2024 | — |
| 0 (this device) | K243493 | Agilis NxT Steerable Introducer Dual-Reach | Abbott Medical | 2024 | — |
| +1 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™… | Abbott Medical | 2025 | — |
| +2 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | — |
| +2 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)Summary page 5…on Name 21 CFR 870.1340 Catheter Introducer Product Code DYB - Introducer, catheter Predicate Device Agilis™ NxT Steerable Introducer Dual-Reach (K241370 – Cleared on 13thJune-2024) Device Description The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use de… | 2024 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… | 2025 | 2 |
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 27 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K251211 (Abbott Medical, 2025) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
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 as stated in the FDA summary.
https://510kreport.com/device/K243493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243493: 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/K243493
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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