# K072929: Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 7, 2007 after 52 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- 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 K920156 (1992). 2 ancestors in all.
2 later devices descend 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)
- K022554: Monitorr Icp External CSF Drainage and Monitoring System, Integra Neurosciences (2002) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Apr 8, 2019 · Class I · Z-1312-2019: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

## Indications for use
The LimiTorr Volume Limiting External 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/K072929
Methodology: https://510kreport.com/methodology