# LRC: Instrument, Ent Manual Surgical

- Device class: 1; regulation: 21 CFR 874.4420; FDA's rule: 510(k) exempt
- FDA decisions: 65
- 510(k) review time 2021–2025: median 135 days (middle half 125–146)
- Recalls: 3 (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: 7
- 2014: 3
- 2015: 6
- 2016: 3
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 4
- 2022: 1
- 2023: 1

## Most-cited predicates
- K102003: Xpress Balloon Device (2010), cited by 7
- K111254: Relieva Solo Elite Sinus Balloon Catheter (2011), cited by 5
- K111875: Relieva Spin Sinus Dilation System (2011), cited by 4
- K043527: Relieva Sinus Balloon Dilation Catheter (2005), cited by 4
- K061903: Relieva Sinus Balloon Catheter (2006), cited by 3
- K121943: Xpress Multi-Sinus Dilation Tool (2012), cited by 3
- K121351: Sinus Dilation System (2012), cited by 3
- K132297: EM Sinus Dilation System (2013), cited by 3
- K121174: Xpress Multi-Sinus Dilation Tool (2012), cited by 3
- K141916: Pathassist Led Light Fiber (2014), cited by 2

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