# GWM: Device, Monitoring, Intracranial Pressure

- Device class: 2; regulation: 21 CFR 882.1620; FDA's rule: 510(k) required
- FDA decisions: 105
- 510(k) review time 2021–2025: median 139 days (middle half 115–210)
- Recalls: 42 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 2
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 2
- 2020: 3
- 2021: 2
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/) (1996), cited by 9
- K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe (2000), cited by 9
- K914479: Microsensor Intracranial Pressure Transducer (1994), cited by 6
- K103206: Raumedic- Icp-Monitoring System (2011), cited by 4
- K121573: Integra Camino Icp Monitor (2012), cited by 3
- K013930: Neurosensor (2002), cited by 3
- K062584: Pressio Icp Monitoring System (2007), cited by 3
- K853864: Intracranial Pressure Monitoring Kit 070 (1986), cited by 3
- K974088: Codman Intracranial Bolt (1998), cited by 3
- K980380: Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite MS (1999), cited by 3

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