FDA product code · Gastroenterology and urology
Catheter, Hemodialysis, Implanted, Coated
2 FDA decisions since 2006. 9 recalls name this code, 0 of them Class I. The most-cited predicate is K060509, named by 2 later devices.
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NYU 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 · NYU
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NYU
Too few NYU 510(k)s in any year since 2007 to give a median.
Recalls per year · NYU
5in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NYU
5in 2025
MAUDE reports naming product code NYU, 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 | 1 |
| 2008 | 0 | — | 4 | 0 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 5 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
Planning a device in NYU? 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) ReportRelated product codes
Other codes under 21 CFR 876.5540.