PMA · Approved
Recalled · Class II · 2020Formula Balloon-Expandable Renal Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Medical Incorporated · NIN Stent, Renal
Approved on Jan 14, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 179-day review. It has been recalled once.
- Decided
- Jan 14, 2011
- Review
- 179 days
- Class
- Class III
- Product code
- NIN
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100028 has 4 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 |
| 2014 | 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 NIN? 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 |
|---|---|---|---|---|
| Apr 15, 2020 | Class II | Z-1940-2020 | Under Investigation by firm | The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIN devicesNIN Stent, Renal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NIN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIN
Too few NIN 510(k)s in any year since 2007 to give a median.
Recalls per year · NIN
No recall names NIN since 2007.
Adverse event reports per year · NIN
42in 2025
MAUDE reports naming product code NIN, 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 | 8 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 4 | — | 0 | 11 |
| 2010 | 10 | — | 0 | 4 |
| 2011 | 13 | — | 0 | 21 |
| 2012 | 25 | — | 0 | 38 |
| 2013 | 11 | — | 0 | 45 |
| 2014 | 14 | — | 0 | 28 |
| 2015 | 8 | — | 0 | 70 |
| 2016 | 11 | — | 0 | 34 |
| 2017 | 12 | — | 0 | 61 |
| 2018 | 6 | — | 0 | 123 |
| 2019 | 4 | — | 0 | 62 |
| 2020 | 4 | — | 0 | 55 |
| 2021 | 4 | — | 0 | 47 |
| 2022 | 4 | — | 0 | 39 |
| 2023 | 6 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 53 |
| 2025 | 2 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P100028 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100028: Formula Balloon-Expandable Renal Stent System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P100028
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026