# DRC: Trocar

- Device class: 2; regulation: 21 CFR 870.1390; FDA's rule: 510(k) exempt
- FDA decisions: 51
- 510(k) review time 2021–2025: median 93 days (middle half 30–178)
- Recalls: 6 (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)
- 2008: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 2
- 2017: 2
- 2018: 2
- 2021: 1
- 2022: 2
- 2024: 2

## Most-cited predicates
- K122587: BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 (2013), cited by 4
- K011727: Transseptal Needle/Trocar (2002), cited by 4
- K072278: BRK Transseptal Needle (2007), cited by 3
- K172950: TSN Transseptal Needle (2018), cited by 1
- K061070: Hansen Medical Transseptal Needle and Dilator (2006), cited by 1
- K170671: SafeSept Transseptal Guidewire (2017), cited by 1
- K172934: Needle Free Transseptal Cannula (2018), cited by 1
- K974745: Manan Gwi Guide Wire Introducer (1998), cited by 1
- K130843: Safesept Needle Free Transseptal Trocar Guidewire (2014), cited by 1
- K911462: Surgical Trocar (1991), cited by 1

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