FDA product code · Gastroenterology and urology
System, Irrigation, Urological
30 FDA decisions since 1982. 1 recall names this code; it is not Class I. The most-cited predicate is K970946, named by 1 later device.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LJH 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 · LJH
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LJH
77in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJH
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJH
25in 2025
MAUDE reports naming product code LJH, 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 | 77 | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 27 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 97 |
| 2015 | 0 | — | 0 | 642 |
| 2016 | 0 | — | 0 | 32 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
Planning a device in LJH? 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 876.5130.