# K945585: Coman (R) CU-11 Model Number 82-6634

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Oct 26, 1995 after 346 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062584: Pressio Icp Monitoring System (2007), 8 descendants of its own
- K103206: Raumedic- Icp-Monitoring System (2011), 7 descendants of its own
- K112017: Raumedic Icp Monitoring System (2011), 6 descendants of its own
- K120252: Raumedic-Icp-Temp-Monitoring-System (2012), 5 descendants of its own
- K130529: Raumedic-Pto-Monitoring-System (2013), 4 descendants of its own

Source page: https://510kreport.com/device/K945585
Methodology: https://510kreport.com/methodology