# LQZ: Device, Jaw Repositioning

- Device class: 2; regulation: 21 CFR 872.5570; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 135 days (middle half 114–173)
- 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)
- 2006: 2
- 2009: 2
- 2011: 1
- 2012: 2
- 2013: 1
- 2017: 1
- 2020: 2
- 2021: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K130130: Atg/SM-Osa Appliances (2013), cited by 6
- K955503: Adjustable PM Positioner (1996), cited by 4
- K032410: Snorenti (2005), cited by 4
- K191320: Slow Wave DS8 (2020), cited by 3
- K960673: OSAP (1996), cited by 3
- K113201: Narval CC (2011), cited by 3
- K091035: Full Breath Sleep Appliance Lower (FBSL) (2009), cited by 3
- K052862: Full Breath Sleep Appliance - AB (Anterior Bite) (2005), cited by 2
- K053065: Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps) (2006), cited by 2
- K233754: AIO Breathe (2024), cited by 1

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