# LNS: Lithotriptor, Extracorporeal Shock-Wave, Urological

- Device class: 2; regulation: 21 CFR 876.5990; FDA's rule: 510(k) required
- FDA decisions: 69
- 510(k) review time 2021–2025: median 308 days (middle half 260–364)
- 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)
- 2012: 3
- 2013: 2
- 2014: 2
- 2015: 2
- 2017: 2
- 2020: 1
- 2021: 1
- 2023: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- P840008: Dornier Lithotripter Compact Transportable (DLCT) (1984), cited by 7
- K002929: Dornier Compact Alpha Lithotripter (2001), cited by 5
- K023535: Tripter X-1 Compact Duet (2003), cited by 4
- K041582: Modification to Tripter X-1 Compact Duet (2004), cited by 4
- K003529: Sonolith Praktis, Endourology Table Praktis (2001), cited by 4
- K010340: Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi (2001), cited by 4
- K053640: Integra (2006), cited by 4
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter (2003), cited by 3
- K011106: Stonelith, Model V5 (2002), cited by 3
- K121656: Gemini Lithotripter (2012), cited by 3

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