# DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

- Device class: 2; regulation: 21 CFR 870.1220; FDA's rule: 510(k) required
- FDA decisions: 187
- 510(k) review time 2021–2025: median 137 days (middle half 66–276)
- Recalls: 20 (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)
- 2017: 7
- 2018: 1
- 2019: 10
- 2020: 4
- 2021: 12
- 2022: 8
- 2023: 5
- 2024: 4
- 2025: 3
- 2026: 2

## Most-cited predicates
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System (1997), cited by 12
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter (2004), cited by 11
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04, (2010), cited by 9
- K022380: Livesire Electrophysiology Catheter (2002), cited by 8
- K931794: Marinr Series EP Diagnostic Catheters (1994), cited by 7
- K002976: Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX and 401XXX (2000), cited by 7
- K894500: Daig Electrophysiology Catheter (1989), cited by 7
- K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter (1995), cited by 7
- K924163: Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec (1993), cited by 6
- K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 (2000), cited by 6

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