# DTZ: Oxygenator, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4350; FDA's rule: 510(k) required
- FDA decisions: 255
- 510(k) review time 2021–2025: median 169 days (middle half 124–336)
- Recalls: 70 (3 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: 3
- 2019: 5
- 2020: 5
- 2021: 5
- 2022: 2
- 2023: 5
- 2024: 3
- 2025: 2
- 2026: 3

## Most-cited predicates
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000 (2009), cited by 12
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface (1998), cited by 11
- K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface (1994), cited by 8
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir (2002), cited by 8
- K891687: Extracorporeal Circuit with Bio-Active Surface (1989), cited by 8
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator (2002), cited by 6
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior (2012), cited by 5
- K000430: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive Surface, Model CB511 (2000), cited by 5
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy (2002), cited by 5
- K180448: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (2018), cited by 5

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