# DTK: Filter, Intravascular, Cardiovascular

- Device class: 2; regulation: 21 CFR 870.3375; FDA's rule: 510(k) required
- FDA decisions: 84
- 510(k) review time 2021–2025: median 41 days (middle half 29–52)
- Recalls: 20 (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)
- 2011: 2
- 2012: 5
- 2013: 3
- 2014: 2
- 2015: 2
- 2016: 3
- 2017: 5
- 2018: 2
- 2021: 2
- 2024: 5

## Most-cited predicates
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set (2008), cited by 6
- K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set (2003), cited by 4
- K090140: Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter (2009), cited by 4
- K031328: Recovery Filter System, Model RF-048F (2003), cited by 4
- K000062: Cordis Trapease Permanent Vena Cava Filter and Introduction Kit (2000), cited by 3
- K912035: Stainless Steel Green Vena Cava Filt W/12F Intr SY (1995), cited by 3
- K101431: Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits (2010), cited by 3
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F (2004), cited by 3
- K000855: Gunther Tulip Vena Cava Mreye Filter Set (2000), cited by 3
- K050558: Modification to:  Recovery Filter System, Model RF-210F (2005), cited by 2

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