# K152670: DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jan 22, 2016 after 127 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
Longest line of descent: 1 generation back to K945585 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945585: Coman (R) CU-11 Model Number 82-6634, Johnson & Johnson Professionals, Inc. (1995) Summary page 4.

## Indications for use
The intended use of the DirectLink Module is to enable the connection of Codman intracranial pressure sensors to an available invasive blood pressure input channel on select commercially available third party patient bedside monitor systems. The DirectLink ICP Extension Cable is intended for use as a connecting cable between the DirectLink ICP Module and a Codman Microsensor ICP Transducer. The Patient Monitor Interface Cable is intended for use as a connecting cable between DirectLink ICP Module, and selected patient monitors available from third party suppliers.

Source page: https://510kreport.com/device/K152670
Methodology: https://510kreport.com/methodology