# K183406: CereLink ICP Monitor, CereLink ICP Extension Cable

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Jan 11, 2019 after 32 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K210993: CereLink ICP Monitor (2021), 1 descendant of its own
- K232890: CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (2024), 0 descendants of its own

## Recalls of this device
- Sep 12, 2019 · Class II · Z-0124-2020: There is a potential for a progressive decline in observed ICP readings of the monitor during use.

Source page: https://510kreport.com/device/K183406
Methodology: https://510kreport.com/methodology