# DRS: Transducer, Blood-Pressure, Extravascular

- Device class: 2; regulation: 21 CFR 870.2850; FDA's rule: 510(k) required
- FDA decisions: 149
- 510(k) review time 2021–2025: median 224 days (middle half 201–246)
- Recalls: 190 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 3
- 2012: 1
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 3
- 2017: 2
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit (2006), cited by 5
- K841788: Utah Disposable Pressure Transducer (1985), cited by 4
- K043065: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1P (2005), cited by 3
- K101518: Compass Vascular Access; Compass Lumbar Puncture (2010), cited by 3
- K842352: Pressure Monitoring Kit (1985), cited by 2
- K832907: Invasive Monitoring Kits (1984), cited by 2
- K951129: Novatrans II (1995), cited by 2
- K961404: MX960 Reusable Pressure Transducer (1996), cited by 2
- K152980: Flo Trac sensor, Volume View sensor (2016), cited by 2
- K070710: Accutrans Disposable Pressure Monitoring System (2007), cited by 2

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