# DSJ: Alarm, Blood-Pressure

- Device class: 2; regulation: 21 CFR 870.1100; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1991: 1
- 1996: 1
- 2014: 1
- 2015: 1
- 2017: 1
- 2019: 1

## Most-cited predicates
- K133961: Suresigns VS3, Suresigns VS4 (2014), cited by 2
- K151761: SureSigns VS3, SureSigns VS4 (2015), cited by 2
- K163649: SureSigns VS3; SureSigns VS4 (2017), cited by 1
- K910262: Keller Vital Signs Monitor - KMS-890 (1991), cited by 1

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