# DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

- Device class: 2; regulation: 21 CFR 870.4260; FDA's rule: 510(k) required
- FDA decisions: 96
- 510(k) review time 2021–2025: median 124 days (middle half 105–149)
- Recalls: 3 (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)
- 2007: 3
- 2008: 1
- 2009: 5
- 2010: 2
- 2011: 1
- 2012: 2
- 2013: 1
- 2023: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- K002493: Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter (2000), cited by 5
- K943917: Capiox Arterial Filter (1995), cited by 4
- K952270: Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen (1995), cited by 3
- K033987: D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters (2004), cited by 3
- K100646: Affinity Pixie Arterial Filter with Balance Biosurface (2010), cited by 3
- K952532: Affinity Arterial Blood Filter (1995), cited by 3
- K001787: Quart Arterial Filter, Model HBF 140 (2000), cited by 2
- K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter (2004), cited by 2
- K914791: Gish Arterial Filter (1993), cited by 2
- K032128: Terumo AL8X Arterial Filter with X-Coating (2003), cited by 2

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