510(k) · Cleared
Recalled · Class II · 2024Agilis NXT Steerable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DYB Introducer, Catheter
Cleared on Jul 12, 2006 as substantially equivalent to K042623 (St. Jude Medical, Daig Division, Inc., 2005) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1997. 2 of the 58 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it. It has been recalled once.
- Decided
- Jul 12, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964518 (1997). 4 ancestors in all. 53 later devices descend from it, 15 citing it directly. 2 of the 58 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 1 generation backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- This deviceK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006
- Descendant · cites it directly · 36 of its ownK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- Descendant · 2 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 5 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 53 · See all- K081645Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008 · cites it directly36descendants
- K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 2 generations on7descendants
- K151951Destino ReachOscor, Inc. · 2015 · 3 generations on6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on5descendants
- K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −1 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| 0 (this device) | K061363 | Agilis NXT Steerable Introducer | St Jude Medical | 2006 | — |
| +1 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| +2 | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +3 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +4 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +5 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 1 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K042623 | Agilis Steerable Catheter Introducer, Model 408304Summary page 1…Product Code: DYB Predicate Devices: Agilis Steerable Catheter Introducer K042623 Livewire Electrophysiology Diagnostic Catheter… | 2005 |
| * | K022380 | Livesire Electrophysiology CatheterSummary page 1…K042623 Livewire Electrophysiology Diagnostic Catheter K022380 Device Description The AgilisTM device is an 8.5 F steerable catheter introducer. The device has a small curl or medium curl at… | 2002 |
What descends from it? (53)
See all 5315 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081645 | Agilis NXT Steerable Introducer, Model G408324 | 2008 | 36 |
| K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | 2024 | 4 |
| K170373 | Flextra Steerable Introducer | 2017 | 4 |
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… | 2025 | 2 |
| K140420 | Vado Steerable Sheath | 2014 | 2 |
| K110450 | Agilis NXT Steerable Introducer | 2011 | 2 |
| K103083 | Agilis ES Steerable Introducer | 2011 | 2 |
| K083402 | Agilis NXT Steerable Introducer, Model G408322 and G408323 | 2008 | 1 |
| K191190 | Steerable Introducer | 2019 | 0 |
| K170311 | Reprocessed Agilis NxT Steerable Introducer | 2017 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2024 | Class II | Z-2348-2024 | Under Investigation by firm | One lot of product has dilators that are too short and will not extend outside the introducer sheath. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K081645 (St Jude Medical, 2008) has gone furthest, with 36 descendants of its own.
- 3 other devices also cite its predicate K042623.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061363: Agilis NXT Steerable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061363
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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