# DRX: Electrode, Electrocardiograph

- Device class: 2; regulation: 21 CFR 870.2360; FDA's rule: 510(k) exempt
- FDA decisions: 329
- Recalls: 19 (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)
- 2004: 6
- 2005: 4
- 2006: 4
- 2007: 3
- 2008: 3
- 2009: 7
- 2010: 5
- 2013: 1
- 2014: 1
- 2017: 1

## Most-cited predicates
- K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes (1999), cited by 6
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200 (2000), cited by 4
- K011564: Neolead (2002), cited by 4
- K043361: Accuheart Electrode Belt (2005), cited by 3
- K940802: Zipprep Electrode (1994), cited by 3
- K911529: Bunny Electrode/Stealth Electrode Pre Wired Eeg (1992), cited by 3
- K030509: Skintact Ecg Tab Electrode (2003), cited by 3
- K123658: Biomodule 3-M1 (2013), cited by 3
- K960968: Medi-Trace 200, Medi-Trace 200-30 (1996), cited by 3
- K944260: Ecg Electrode (1995), cited by 2

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