# LQC: Lithotriptor, Biliary Mechanical

- Device class: 2; regulation: 21 CFR 876.4500; FDA's rule: 510(k) exempt
- FDA decisions: 11
- Recalls: 7 (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)
- 1986: 1
- 1990: 1
- 1991: 4
- 1994: 2
- 1997: 1
- 2001: 1
- 2004: 1

## Most-cited predicates
- K040447: Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088 (2004), cited by 1
- K964937: A Lithotripter-Compatible Basket (1997), cited by 1
- K943191: Microvasive (R) Monolith (TM) Mechanical Lithotriptor (1994), cited by 1

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