# K191684: MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Oct 11, 2019 after 109 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920156 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 5 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 4.
- K022554: Monitorr Icp External CSF Drainage and Monitoring System, Integra Neurosciences (2002) Summary page 4.
- K072929: Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030, Integra LifeSciences Corporation (2007) Summary page 4.

## Most influential descendants
- K221694: External Drainage System (2023), 0 descendants of its own

## 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. The LimiTorr™ 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 to monitor ICP.

Source page: https://510kreport.com/device/K191684
Methodology: https://510kreport.com/methodology