# LJH: System, Irrigation, Urological

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 30
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 2
- 1999: 1
- 2000: 1
- 2001: 2
- 2003: 1
- 2004: 2
- 2006: 1
- 2007: 3
- 2017: 1
- 2026: 2

## Most-cited predicates
- K042457: Uro Pro (2004), cited by 1
- K980808: Endo FMS Urology (1998), cited by 1
- K162992: Karl Storz UROMAT E.A.S.I. (2017), cited by 1
- K970946: Medline Y-Type Tur/Bladder Irrigation Set (1997), cited by 1
- K981615: Ksea Uropump (1998), cited by 1
- K960787: Tur,Arthroscopic,Cystoscopy Irrigation Sets (1996), cited by 1
- K940983: The Karl Storz Uromat (TM) (1994), cited by 1

Source page: https://510kreport.com/product-code/LJH
Data by year (CSV): https://510kreport.com/product-code/LJH.csv