FDA product code · Cardiovascular

Stent, Renal

Name: FDA decisions, review times, recalls and adverse event reports for product code NIN
Creator: 510(k) Report

NINClass IIIPMA required5 decisions since 19910 recalls

5 FDA decisions since 1991. No recall names this code.

Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of NIN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NIN

2in 2025

2007high 25 (2012) · low 0 (2007)2026

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

2007high 123 (2018) · low 4 (2010)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	MAUDE reports
2007	0	—	8
2008	1	—	10
2009	4	—	11
2010	10	—	4
2011	13	—	21
2012	25	—	38
2013	11	—	45
2014	14	—	28
2015	8	—	70
2016	11	—	34
2017	12	—	61
2018	6	—	123
2019	4	—	62
2020	4	—	55
2021	4	—	47
2022	4	—	39
2023	6	—	47
2024	0	—	53
2025	2	—	42
2026	0	—	—

FIG. 1 — NIN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NIN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Stent, Renal

What has FDA decided in NIN lately?