# DSK: Computer, Blood-Pressure

- Device class: 2; regulation: 21 CFR 870.1110; FDA's rule: 510(k) required
- FDA decisions: 77
- 510(k) review time 2021–2025: median 156 days (middle half 156–156)
- Recalls: 0 (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)
- 1996: 1
- 1999: 1
- 2001: 5
- 2002: 1
- 2004: 1
- 2007: 1
- 2008: 1
- 2015: 2
- 2016: 1
- 2023: 1

## Most-cited predicates
- K070795: Sphygmocor Cardiovascular Management System (2007), cited by 5
- K002067: Radianalyzer, Model 12710 (2001), cited by 2
- K013943: Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720 (2001), cited by 2
- K003122: Smartflow, Model Sfip 2000 (2001), cited by 2
- K080670: Modification to Sphygmocor Cardiovascular Management System (2008), cited by 2
- K160945: Endophys Blood Pressure Monitor (2016), cited by 1
- K871720: Modified Model UA-731 Digital Sphygmomanometer (1987), cited by 1
- K002742: Sphygmocor MX Model Scor-MX (2001), cited by 1
- K811146: Vita-Stat Model 8000-C (1981), cited by 1
- K011865: Zoll M Series Ibp Operation; Zoll M Series Temperature Option (2001), cited by 1

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