# DQE: Catheter, Oximeter, Fiber-Optic

- Device class: 2; regulation: 21 CFR 870.1230; FDA's rule: 510(k) required
- FDA decisions: 19
- 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)
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 1
- 2006: 6
- 2009: 1
- 2011: 1
- 2014: 1
- 2016: 1
- 2018: 1

## Most-cited predicates
- K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor (2006), cited by 4
- K060093: Presep Oligon Oximetry Catheters (2006), cited by 2
- K820674: Opticath (1982), cited by 2
- K905458: Swan-Ganz (R) Flow Direct Oximetry/Thermod Cather (1991), cited by 2
- K061450: Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters (2006), cited by 1
- K160645: PreSep Oligon Oximetry Catheter (2016), cited by 1
- K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) (2011), cited by 1
- K061585: Opticath Central Venous Oximetry Catheter (2006), cited by 1

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