510(k) · Cleared
Recalled · Class I · 2018Reprocessed Steerable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · PNE Reprocessed Catheter Introducer
Cleared on Mar 23, 2016 as substantially equivalent to K061363 (St Jude Medical, 2006) and 1 other predicate after a 240-day review. Its family tree reaches back 4 generations to 1997. 1 of the 7 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Mar 23, 2016
- Review
- 240 days
- Class
- Class II
- Product code
- PNE
- Recalls
- 2 (1 Class I)
- 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. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- 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 deviceK152090 Reprocessed Steerable IntroducerSterilmed, Inc. · 2016
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) | K152090 | Reprocessed Steerable Introducer | Sterilmed, Inc. | 2016 | — |
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.
1 device in this family has 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 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 |
|---|---|---|---|
| * | K061363 | Agilis NXT Steerable IntroducerSummary page 6…oroscopy. 1.6 PERFORMANCE TESTING OVERVIEW The reprocessed steerable introducer devices are substantially equivalent to the new un- reprocessed predicate devices (K061363 and K081645) in that the reprocessed devices are the same as the new un-reprocessed predicate devices in terms of form, fit, func… | 2006 |
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 6….6 PERFORMANCE TESTING OVERVIEW The reprocessed steerable introducer devices are substantially equivalent to the new un- reprocessed predicate devices (K061363 and K081645) in that the reprocessed devices are the same as the new un-reprocessed predicate devices in terms of form, fit, function, and in… | 2008 |
| † | K935170 | Cardiovascular and Vascular Guidewire Modifications | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2018 | Class II | Z-0090-2019 | Material/Component Contamination | Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. |
| Jun 2, 2017 | Class I | Z-0213-2018 | Process control | Inadequate seal due to lack of adhesive glue |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 14 other devices also cite its predicate K061363.
How does its category compare?
All PNE devicesPNE Reprocessed Catheter Introducer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 steerable introducer devices are 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/K152090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152090: Reprocessed 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/K152090
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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