510(k) · Cleared
ClearedReprocessed Agilis NxT Steerable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · PNE Reprocessed Catheter Introducer
Cleared on Jun 2, 2017 as substantially equivalent to K081645 (St Jude Medical, 2008) and 1 other predicate after a 121-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jun 2, 2017
- Review
- 121 days
- Class
- Class II
- Product code
- PNE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964518 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
- This deviceK170311 Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC · 2017
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 | K081645 | Agilis NXT Steerable Introducer, Model G408324 | St Jude Medical | 2008 | — |
| 0 (this device) | K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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 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? (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 |
|---|---|---|---|
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 5…Product Code: PNE Predicate Device: 510(k) Number Device Manufacturer K081645 Agilis NxT Steerable Introducer St. Jude Medical K061363 Agilis NxT Steera… | 2008 |
| * | K061363 | Agilis NXT Steerable IntroducerSummary page 5…Device Manufacturer K081645 Agilis NxT Steerable Introducer St. Jude Medical K061363 Agilis NxT Steerable Introducer St. Jude Medical Device Description: The reprocesse… | 2006 |
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 20 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.
- 15 other devices also cite its predicate K081645.
How does its category compare?
All PNE devicesPNE Reprocessed Catheter Introducer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Reprocessed Agilis NxT Steerable Introducer is indicated when 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/K170311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170311: Reprocessed 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/K170311
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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