510(k) · Cleared
ClearedAgills PF Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Cardiac Rhythm Management Divisi · DYB Introducer, Catheter
Cleared on Sep 29, 2011 after an 83-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 9 later devices descend from it.
- Decided
- Sep 29, 2011
- Review
- 83 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
9 later devices descend from it, 5 citing it directly.
- This deviceK111943 Agills PF Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011
- Descendant · cites it directly · 1 of its ownK233959 EPi-Ease Epicardial Access Device (EAS)AtriCure, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK210185 CardioCurve Steerable SheathTalon Surgical · 2021
- Descendant · cites it directly · 1 of its ownK191546 Epicardial Access SystemBaylis Medical Company, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK142245 EpiAccess SystemEpiep, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK243954 PeriCross™ Epicardial Access KitCirca Scientific, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K233959EPi-Ease Epicardial Access Device (EAS)AtriCure, Inc. · 2024 · cites it directly1descendant
- K210185CardioCurve Steerable SheathTalon Surgical · 2021 · cites it directly1descendant
- K191546Epicardial Access SystemBaylis Medical Company, Inc. · 2019 · cites it directly1descendant
- K142245EpiAccess SystemEpiep, Inc. · 2014 · cites it directly1descendant
- K243954PeriCross™ Epicardial Access KitCirca Scientific, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111943 | Agills PF Delivery System | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011 | — |
| +1 | K233959 | EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. | 2024 | — |
| +1 | K210185 | CardioCurve Steerable Sheath | Talon Surgical | 2021 | — |
| +1 | K191546 | Epicardial Access System | Baylis Medical Company, Inc. | 2019 | — |
| +1 | K142245 | EpiAccess System | Epiep, Inc. | 2014 | — |
| +1 | K243954 | PeriCross™ Epicardial Access Kit | Circa Scientific, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K402049 | St Jude Medical Agilis NxT Steerable Introducer Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…The subject device is equivalent to the following St Jude Medical Device St Jude Medical Agilis NxT Steerable Introducer - G402049 and 17 Gauge Tuohy Needle St. Jude Medical Fast Cath Introducer (… | |
| * | — | St. Jude Medical Fast Cath Introducer Named without a submission number |
What descends from it? (9)
5 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?
- Of its descendants, K233959 (AtriCure, Inc., 2024) has gone furthest, with 1 descendant 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. 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 AgilisiTM PF Introducer System is intended to access the epicardial
surface of the heart via a subxiphoid approach to facilitate electrophysiology studies
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/K111943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111943: Agills PF Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111943
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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