# DRB: Stylet, Catheter

- Device class: 2; regulation: 21 CFR 870.1380; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 210 days (middle half 210–210)
- 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)
- 2001: 2
- 2004: 1
- 2005: 1
- 2006: 2
- 2008: 2
- 2009: 1
- 2014: 1
- 2017: 1
- 2019: 2
- 2022: 1

## Most-cited predicates
- K905674: Lead Stylet (1991), cited by 4
- K992664: TFX Medical Stylet Catheter (2000), cited by 1
- K010906: Medtronic Stylet Kit, Models 6282, 6293, and 6254 (2001), cited by 1
- K990713: Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister (1999), cited by 1
- K182660: GaltTWS (2019), cited by 1
- K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 (2009), cited by 1

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