# K920156: Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Neuro Systems, LLC
- Decided: Mar 16, 1992 after 62 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
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022554: Monitorr Icp External CSF Drainage and Monitoring System (2002), 4 descendants of its own
- 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
- K983799: Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl (1999), 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-1310-2019: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Source page: https://510kreport.com/device/K920156
Methodology: https://510kreport.com/methodology