FDA product code · Gastroenterology and urology
Hemodialysis System For Home Use
4 FDA decisions since 2011. 510(k) reviews decided 2021–2025 took a median of 92 days (half between 92 and 92). 4 recalls name this code, 0 of them Class I. The most-cited predicate is K124035, named by 2 later devices.
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of ONW 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 · ONW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ONW
Too few ONW 510(k)s in any year since 2007 to give a median.
Recalls per year · ONW
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONW
1in 2025
MAUDE reports naming product code ONW, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 2 | — | 3 | 8 |
| 2014 | 0 | — | 0 | 35 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
Planning a device in ONW? 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 876.5860.