# DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4290; FDA's rule: 510(k) exempt
- FDA decisions: 137
- Recalls: 20 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 1
- 2006: 2
- 2007: 1
- 2008: 5
- 2009: 2
- 2010: 4
- 2012: 8
- 2013: 1
- 2014: 2
- 2015: 1

## Most-cited predicates
- K991102: Copilot Bleedback Control Valve, Model 1003331 (1999), cited by 7
- K040498: Myshell (2004), cited by 4
- K791498: Adapter-Y Type/Coronary Perfusion (1979), cited by 4
- K042060: Easypass US Y-Connector Hemostatic Valve (2004), cited by 4
- K963749: High Pressure Injection Lines (1996), cited by 4
- K934123: Stopcock (One-Port Manifold) (1993), cited by 3
- K790563: Adapters-Y-Type (1979), cited by 3
- K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface (2012), cited by 3
- K925419: Passage Hemostasis Valve (1993), cited by 3
- K041697: Terumo Circuit Connectors (2004), cited by 3

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