510(k) · Cleared
ClearedAgilis ES 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 Apr 8, 2011 as substantially equivalent to K061363 (St Jude Medical, 2006) and 2 other predicates after a 171-day review. Its family tree reaches back 6 generations to 1989. 2 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K893658 (1989). 50 ancestors in all, the oldest K760385 (1976). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 4 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 3 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 2 generations backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- 1 generation backK052575 Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical · 2006
- This deviceK103083 Agilis ES Steerable IntroducerSt Jude Medical · 2011
- Descendant · cites it directly · 1 of its ownK171557 AcQRef Introducer SheathAcutus Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK192106 AcQRef Introducer SheathAcutus Medical, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −6 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −5 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −4 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −3 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −2 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| −1 | K052575 | Luminary Cannulator Bideflectable Catheter with Lumen | St Jude Medical | 2006 | — |
| 0 (this device) | K103083 | Agilis ES Steerable Introducer | St Jude Medical | 2011 | — |
| +1 | K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018 | — |
| +2 | K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K061363 | Agilis NXT Steerable IntroducerSummary page 1…Class 11, 21 CER 870.1220, Product Code DRF Predicate Device: St. Jude Medical AgiliSTm NxT Steerable Introducer, Catheter Introducer (K061363/K081645) St. Jude Medical CPS® Luminary Bi-Deflectable Catheter with Lumen (K052575) Device Description: The St. Jude Medical… | 2006 |
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 1…Class 11, 21 CER 870.1220, Product Code DRF Predicate Device: St. Jude Medical AgiliSTm NxT Steerable Introducer, Catheter Introducer (K061363/K081645) St. Jude Medical CPS® Luminary Bi-Deflectable Catheter with Lumen (K052575) Device Description: The St. Jude Medical Agilis E… | 2008 |
| * | K052575 | Luminary Cannulator Bideflectable Catheter with LumenSummary page 1…te Device: St. Jude Medical AgiliSTm NxT Steerable Introducer, Catheter Introducer (K061363/K081645) St. Jude Medical CPS® Luminary Bi-Deflectable Catheter with Lumen (K052575) Device Description: The St. Jude Medical Agilis ES Steerable Introducer consists of a 94cm, 8.5F7 dilator; a 180cm, 0.032" gu… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171557 | AcQRef Introducer Sheath | 2018 | 1 |
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 22 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 11 of the 50 ancestors have a recall of any class.
- Of its descendants, K171557 (Acutus Medical, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K061363.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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™ ES Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The Introducer may be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103083: Agilis ES 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/K103083
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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