PMA · Approved
ApprovedAssurant Cobalt Iliac Balloon-Expandable Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Ireland · NIO Stent, Iliac
Approved on Oct 26, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 208-day review.
- Decided
- Oct 26, 2011
- Review
- 208 days
- Class
- Class III
- Product code
- NIO
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P110011 has 12 supplements since 2011: 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 |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 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.
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)
No FDA recall names this device.
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. 2011, this device’s year, is highlighted.
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/P110011 · printed Nov 6, 2026
Cite this page
510(k) Report. “P110011: Assurant Cobalt Iliac Balloon-Expandable Stent System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P110011
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026