# K062599: Monitorr Icp External Drainage and Monitoring Systems

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Sep 27, 2006 after 26 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- 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: 2 generations back to K920156 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
3 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920156: Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY, Clinical Neuro Systems, LLC (1992) Summary page 1.
- K022554: Monitorr Icp External CSF Drainage and Monitoring System, Integra Neurosciences (2002) Summary page 1.

## Recalls of this device
- Apr 8, 2019 · Class I · Z-1311-2019: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
- Apr 8, 2019 · Class I · Z-1310-2019: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

## Indications for use
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.

Source page: https://510kreport.com/device/K062599
Methodology: https://510kreport.com/methodology