# NCX: System, Hypothermia, Intravenous, Cooling

- Device class: 2; regulation: 21 CFR 870.5900; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 90 days (middle half 60–120)
- Recalls: 35 (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)
- 2006: 1
- 2007: 6
- 2008: 3
- 2010: 1
- 2014: 1
- 2015: 1
- 2016: 3
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K012512: Setpoint Endovascular Temperature Management System (2002), cited by 7
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), cited by 5
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D (2003), cited by 5
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), cited by 3
- K080899: Arctic Blast Intravenous Fluid Chiller (2008), cited by 2
- K052443: Icy Catheter, Model IC-3893A (2005), cited by 2
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), cited by 2
- K022366: Celsius Control System (2003), cited by 2
- K213031: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console (2021), cited by 2
- K060308: Coolgard 3000 (2006), cited by 1

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