# K232890: CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Production Corporation
- Decided: Feb 4, 2024 after 139 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K183406 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210993: CereLink ICP Monitor, Integra Lifesciences Production Corporation (2021) Summary page 5.

## Recalls of this device
- Oct 5, 2023 · Class I · Z-0548-2024: Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the ex

## Indications for use
The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

Source page: https://510kreport.com/device/K232890
Methodology: https://510kreport.com/methodology