# FFK: Lithotriptor, Electro-Hydraulic

- Device class: 2; regulation: 21 CFR 876.4480; FDA's rule: 510(k) required
- FDA decisions: 61
- 510(k) review time 2021–2025: median 184 days (middle half 178–208)
- Recalls: 11 (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)
- 2005: 1
- 2007: 2
- 2010: 2
- 2012: 2
- 2013: 3
- 2016: 2
- 2019: 1
- 2021: 1
- 2023: 1
- 2025: 2

## Most-cited predicates
- K963285: Ems Swiss Lithoclast Lithotripter (1997), cited by 8
- K951531: Swiss Lithoclast Lithotripter (1995), cited by 8
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) (2001), cited by 5
- K052135: Cybersonics Cyberwand Dual Probe Lithotripter (2005), cited by 3
- K130368: Autolith Touch; Uro Touch (2013), cited by 2
- K120303: Cyberwand Dual Action Ultrasonic Lithotripsy System (2012), cited by 2
- K230488: EL27-Compact; Sterile EHL-Probes (2023), cited by 2
- K102169: Cyberwand Lithotripter (2010), cited by 2
- K011065: Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono) (2001), cited by 1
- K914514: 1.9 French Lithotripter Electrode, Modification (1992), cited by 1

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