# DTR: Heat-Exchanger, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4240; FDA's rule: 510(k) required
- FDA decisions: 91
- 510(k) review time 2021–2025: median 121 days (middle half 109–136)
- Recalls: 32 (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)
- 2008: 1
- 2009: 2
- 2017: 2
- 2018: 1
- 2020: 2
- 2022: 2
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K904171: Scimed Cardiotherm Cardioplegia Delivery System (1990), cited by 4
- K925369: BCD Advanced Blood Carioplegia Systems (1993), cited by 3
- K003724: Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B (2000), cited by 3
- K953838: Myocardial Protection System (1996), cited by 2
- K896807: SPBC Series Single Pass Blood Cardioplegia System (1990), cited by 2
- K012898: Modification to: CSC14 Blood Cardioplegia System (2001), cited by 2
- K020106: Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger (2002), cited by 2
- K923311: Conducer Heat Exchanger (1992), cited by 2
- K162774: MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) (2017), cited by 1
- K212688: Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (2022), cited by 1

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