# DSI: Detector And Alarm, Arrhythmia

- Device class: 2; regulation: 21 CFR 870.1025; FDA's rule: 510(k) required
- FDA decisions: 398
- 510(k) review time 2021–2025: median 210 days (middle half 159–256)
- Recalls: 60 (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)
- 2014: 4
- 2015: 9
- 2016: 6
- 2018: 2
- 2019: 3
- 2020: 2
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. (2003), cited by 37
- K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 (2008), cited by 20
- K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 (2009), cited by 18
- K971910: Multi-Parameter Module (M3000A)/Display Unit (M3046A) (1998), cited by 12
- K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 (2009), cited by 12
- K014159: Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor (2002), cited by 10
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System (1995), cited by 9
- K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P (1999), cited by 8
- K990125: HP Viridia Component Monitoring System, Model Rev. K (1999), cited by 8
- K964122: HP Star ST and Arrhhythmia Software (1997), cited by 8

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