# DTN: Reservoir, Blood, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4400; FDA's rule: 510(k) required
- FDA decisions: 169
- 510(k) review time 2021–2025: median 137 days (middle half 66–200)
- Recalls: 10 (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)
- 2009: 7
- 2010: 1
- 2011: 2
- 2013: 4
- 2014: 3
- 2015: 2
- 2017: 2
- 2023: 1
- 2024: 2
- 2025: 1

## Most-cited predicates
- K920774: MVR Collapsible Venous Reservoir Bag (1992), cited by 5
- K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems (1994), cited by 4
- K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir (1997), cited by 3
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711 (2003), cited by 3
- K936003: Affinity CVR (1994), cited by 3
- K011864: Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B (2001), cited by 2
- K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag (2005), cited by 2
- K933481: Sorin Monolyth Venous Reservoir (1993), cited by 2
- K872719: Expanded Use of Hardshell Venous Reserv. W/Filter (1987), cited by 2
- K030449: Modification to Capiox SX10 Hardshell Reservoir (2003), cited by 2

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