PMA · Approved
Recalled · Class I · 2013Zilver PTX Drug-Eluting Peripheral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · NIU Stent, Superficial Femoral Artery, Drug-Eluting
Approved on Nov 14, 2012 through premarket approval, which rests on the device’s own clinical evidence after an 894-day review. It has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Nov 14, 2012
- Review
- 894 days
- Class
- Class III
- Product code
- NIU
- Recalls
- 2 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100022 has 43 supplements since 2013: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2013 | 8 |
| 2015 | 6 |
| 2016 | 5 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Apr 18, 2013 | Class I | Z-1275-2013 | Process control | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the… |
| Apr 18, 2013 | Class I | Z-1274-2013 | Process control | Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIU devicesNIU Stent, Superficial Femoral Artery, Drug-Eluting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NIU
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIU
Too few NIU 510(k)s in any year since 2007 to give a median.
Recalls per year · NIU
No recall names NIU since 2007.
Adverse event reports per year · NIU
181in 2025
MAUDE reports naming product code NIU, 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 | 1 | — | 0 | 0 |
| 2013 | 8 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 6 | — | 0 | 168 |
| 2016 | 5 | — | 0 | 232 |
| 2017 | 4 | — | 0 | 279 |
| 2018 | 10 | — | 0 | 194 |
| 2019 | 20 | — | 0 | 295 |
| 2020 | 22 | — | 0 | 319 |
| 2021 | 9 | — | 0 | 225 |
| 2022 | 5 | — | 0 | 254 |
| 2023 | 7 | — | 0 | 248 |
| 2024 | 7 | — | 0 | 175 |
| 2025 | 4 | — | 0 | 181 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P100022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100022: Zilver PTX Drug-Eluting Peripheral Stent.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100022
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026