# LQR: Dislodger, Stone, Biliary

- Device class: 2; regulation: 21 CFR 876.5010; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 193 days (middle half 97–195)
- Recalls: 9 (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)
- 2013: 1
- 2017: 4
- 2018: 3
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K902944: Wittich Nitinol Stone Basket (1990), cited by 4
- K171969: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket (2018), cited by 4
- K173009: NCompass Nitinol Stone Extractors (2017), cited by 2
- K925495: Microvasive Insurg Helical & Mini-Helical Baskets (1992), cited by 2
- K925879: Microvasive Insurg Flat Wire Baskets (1993), cited by 1
- K946358: Endoscopic Biliary Catheter (1995), cited by 1
- K201509: Disposable Stone Extraction basket (2020), cited by 1
- K203322: SpyGlass Discover Retrieval Basket (2021), cited by 1
- K952149: Karl Storz Take-Apart Rotating Grasping Forceps (1995), cited by 1
- K170811: Single Use Retrieval Nitinol Basket V (2017), cited by 1

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