# LQY: Locator, Root Apex

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 207 days (middle half 117–221)
- Recalls: 0 (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)
- 2014: 1
- 2016: 1
- 2018: 2
- 2019: 1
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K921979: Root ZX (1993), cited by 5
- K032743: Apex NRG (2004), cited by 3
- K953867: Root Canal Length Measuring Device (1995), cited by 3
- K071133: Apexnrg-Blue Electronic Apex Locator (2007), cited by 2
- K992233: Apex Locator Bingo-1020 (1999), cited by 2
- K181087: Apex Locator, DPEX III (2018), cited by 2
- K203836: BOMEDENT Apex locator, WISMY Apex locator (2021), cited by 2
- K100450: I-ROOT (2010), cited by 2
- K083901: Navi Root (2009), cited by 2
- K022020: Justwo Model Tme-601 Root Apex Locator (2002), cited by 2

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