# DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

- Device class: 2; regulation: 21 CFR 870.2900; FDA's rule: 510(k) required
- FDA decisions: 105
- 510(k) review time 2021–2025: median 128 days (middle half 90–224)
- Recalls: 3 (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: 5
- 2018: 3
- 2019: 4
- 2020: 6
- 2021: 4
- 2022: 2
- 2023: 3
- 2024: 3
- 2025: 4
- 2026: 1

## Most-cited predicates
- K120010: Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) (2012), cited by 10
- K980582: Multi-Link Cable and Lead Wire Systems (1998), cited by 6
- K771645: Electrocardiographic Cablhs & Lead Wire (1977), cited by 4
- K992524: Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and Leadwires (2000), cited by 3
- K082959: Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors (2008), cited by 3
- K101660: Ecg Single Patient Use Lead Wire Set, Models 2048801-5 to 2048801-8 (2010), cited by 2
- K162768: ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables (2017), cited by 2
- K771027: Electrocardiographic Patient Cables (1977), cited by 2
- K162432: Multi-Link X2 ECG Cable and Lead Wire System (2017), cited by 2
- K942321: Variouspatient Monitoring Cable (1994), cited by 2

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