# K210993: CereLink ICP Monitor

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Production Corporation
- Decided: Apr 30, 2021 after 28 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183406 (2019). 1 ancestor in all.
1 later device descends 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)
- K183406: CereLink ICP Monitor, CereLink ICP Extension Cable, Integra Lifesciences Corp. (2019) Summary page 4.

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

## 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
- Jun 22, 2022 · Class I · Z-1395-2022: Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is 

## 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.

Source page: https://510kreport.com/device/K210993
Methodology: https://510kreport.com/methodology