# FQO: Table, Operating-Room, Ac-Powered

- Device class: 1; regulation: 21 CFR 878.4960; FDA's rule: 510(k) exempt
- FDA decisions: 35
- 510(k) review time 2021–2025: median 146 days (middle half 118–173)
- Recalls: 51 (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)
- 1988: 2
- 1992: 6
- 1993: 4
- 1994: 6
- 1995: 3
- 1996: 3
- 1997: 4
- 2009: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K951854: Leonard Arm - Support Arm - Endoscopic Accessory (1995), cited by 3
- K090136: Steris Cmax XLT Surgical Table (2009), cited by 2
- K921297: Drager Dve 4000 Series System (1992), cited by 2
- K221410: Maestro Platform (2022), cited by 2
- K240598: Maestro System (REF100) (2024), cited by 1
- K942043: Drager Dve 8000/1/2 Series Syst W/Dve 4002 and 8032E (1994), cited by 1
- K831086: Ceiling Mounted Support (1983), cited by 1
- K936308: Endex Endoscopic Positioning System (1994), cited by 1
- K955750: Teletom (1996), cited by 1
- K930493: Quantum 3080 Surgical Table (1993), cited by 1

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