# DXQ: Blood Pressure Cuff

- Device class: 2; regulation: 21 CFR 870.1120; FDA's rule: 510(k) required
- FDA decisions: 199
- 510(k) review time 2021–2025: median 97 days (middle half 63–108)
- Recalls: 17 (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: 2
- 2018: 5
- 2019: 3
- 2020: 3
- 2021: 4
- 2022: 4
- 2023: 5
- 2024: 2
- 2025: 3
- 2026: 4

## Most-cited predicates
- K974080: Critikon Soft Blood Pressure Cuff (1998), cited by 9
- K120364: Unimed Disposable Blood Pressure Cuff (2012), cited by 7
- K112544: Unimed Blood Pressure Cuff (2011), cited by 7
- K182433: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff (2018), cited by 6
- K022482: Sensa-Cuff, Models Infant, Child, Adult (2002), cited by 6
- K151290: Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff (2015), cited by 5
- K190902: RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope (2019), cited by 5
- K883977: Surgi-Cuf Sterile/Non-Sterile Disposable (1989), cited by 4
- K940214: Statcorp Inc. Disposable Blood Pressure Cuff (1994), cited by 4
- K911213: Cuffable (1991), cited by 4

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