PMA · Approved
Recalled · Class II · 2025S.M.a.R.T. and S.M.a.R.T. Control Nitinol Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis US Corporation · NIO Stent, Iliac
Approved on Aug 12, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 341-day review. It has been recalled 4 times.
- Decided
- Aug 12, 2003
- Review
- 341 days
- Class
- Class III
- Product code
- NIO
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020036 has 57 supplements since 2004: 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 |
|---|---|
| 2004 | 1 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 4 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 5 |
| 2026 | 2 |
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.
Planning a device in NIO? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2025 | Class II | Z-1510-2025 | Employee error | product mix-up; Vascular stent labeled as one size but contains a different size. |
| Nov 14, 2019 | Class II | Z-0728-2020 | Under Investigation by firm | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe". |
| Jan 31, 2012 | Not classified | Z-1040-2012 | Packaging | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches. |
| Mar 10, 2008 | Not classified | Z-1556-2008 | Mixed-up of materials/components | Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIO devicesNIO Stent, Iliac: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIO
Too few NIO 510(k)s in any year since 2007 to give a median.
Recalls per year · NIO
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIO
632in 2025
MAUDE reports naming product code NIO, 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 | 3 | — | 0 | 38 |
| 2008 | 4 | — | 1 | 68 |
| 2009 | 7 | — | 0 | 97 |
| 2010 | 14 | — | 0 | 165 |
| 2011 | 23 | — | 0 | 256 |
| 2012 | 34 | — | 1 | 391 |
| 2013 | 47 | — | 0 | 395 |
| 2014 | 33 | — | 0 | 436 |
| 2015 | 27 | — | 1 | 445 |
| 2016 | 22 | — | 0 | 412 |
| 2017 | 18 | — | 0 | 462 |
| 2018 | 16 | — | 0 | 460 |
| 2019 | 22 | — | 1 | 416 |
| 2020 | 21 | — | 0 | 409 |
| 2021 | 12 | — | 0 | 421 |
| 2022 | 15 | — | 0 | 352 |
| 2023 | 16 | — | 0 | 351 |
| 2024 | 12 | — | 0 | 508 |
| 2025 | 14 | — | 0 | 632 |
| 2026 | 15 | — | 0 | — |
https://510kreport.com/device/P020036 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020036: S.M.a.R.T. and S.M.a.R.T. Control Nitinol Stent System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020036
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026