# LRO: General Surgery Tray

- Device class: 2; regulation: 21 CFR 878.4370
- FDA decisions: 110
- 510(k) review time 2021–2025: median 172 days (middle half 154–189)
- Recalls: 551 (93 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 24
- 1995: 6
- 1996: 8
- 1997: 7
- 1998: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K962826: Medline Radiology-Diagnostic Kits (1996), cited by 2
- K970187: Runyon Large Volume Paracentesis Kit (1997), cited by 1
- K934688: Sterile Design (1994), cited by 1
- K913136: Laser Endoscope Disc Decompression Kits (1991), cited by 1
- K880961: Alcon Surgical Procedure Packs (1988), cited by 1
- K930700: Medlines Repeat Performance Surgical Pack System (1993), cited by 1
- K041080: Surgical Drape Kit - D.I.R.R.a. SRL (2004), cited by 1
- K961863: Paracentesis Trays (1996), cited by 1
- K950574: Needle/Cannula (1995), cited by 1
- K932652: Tri-Med Paracentesis Tray (1993), cited by 1

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