# BSO: Catheter, Conduction, Anesthetic

- Device class: 2; regulation: 21 CFR 868.5120; FDA's rule: 510(k) required
- FDA decisions: 75
- 510(k) review time 2021–2025: median 180 days (middle half 159–226)
- Recalls: 3 (1 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: 1
- 2014: 2
- 2015: 1
- 2016: 5
- 2017: 3
- 2018: 2
- 2019: 2
- 2020: 2
- 2023: 2
- 2025: 1

## Most-cited predicates
- K042488: Perifix Catheter and Contiplex Catheter (2004), cited by 6
- K954584: Racz Epidural Catheter (1996), cited by 4
- K981329: Feth-R-Kath (1998), cited by 4
- K043456: Modification to Soaker Catheter (2005), cited by 3
- K063234: ON-Q Introducers (2006), cited by 3
- K022019: Perifix Catheter Connector (2002), cited by 3
- K840202: Epidural Catheter (1984), cited by 3
- K991879: Spring-Wound Epidural Catheter (1999), cited by 3
- K143164: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (2014), cited by 3
- K993592: Axiom Multipurpose Wound Drain (2000), cited by 3

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