# DRY: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4330; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 183 days (middle half 154–212)
- Recalls: 28 (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)
- 2007: 2
- 2009: 2
- 2011: 2
- 2012: 1
- 2014: 2
- 2017: 1
- 2018: 3
- 2020: 1
- 2021: 1
- 2024: 1

## Most-cited predicates
- K972962: 3M Cdi Blood Parameter Monitoring System 500 (1997), cited by 3
- K001388: Data Master Perfusion Monitoring System (2000), cited by 3
- K910421: Saturation/Hematocrit Monitor System (1991), cited by 3
- K072131: M3 Monitor (2007), cited by 2
- K012743: Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T (2001), cited by 2
- K071725: M2 Monitor (2007), cited by 2
- K931968: Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio (1993), cited by 2
- K915265: Cdi (TM) H/S Cuvette, Modification (1992), cited by 1
- K202154: B-Capta (2021), cited by 1
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), cited by 1

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