# K022554: Monitorr Icp External CSF Drainage and Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences
- Decided: Aug 23, 2002 after 21 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: 1 generation back to K920156 (1992). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
4 of 6 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.

## Most influential descendants
- K072929: Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030 (2007), 2 descendants of its own
- K191684: MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System (2019), 1 descendant of its own
- K221694: External Drainage System (2023), 0 descendants of its own
- K062599: Monitorr Icp External Drainage and Monitoring Systems (2006), 0 descendants of its own

## 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 system allows 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 the monitoring of ICP.

Source page: https://510kreport.com/device/K022554
Methodology: https://510kreport.com/methodology