510(k) · Cleared
Recalled · Class I · 2019Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Neuro Systems, LLC · JXG Shunt, Central Nervous System And Components
Cleared on Mar 16, 1992 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 16, 1992
- Review
- 62 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1 (1 Class I)
- Predicates
- 0
7 later devices descend from it, 4 citing it directly. 4 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992
- Descendant · cites it directly · 4 of its ownK022554 Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK072929 Limitorr Volume Limiting External CSF Drainage and Monitoring…Integra LifeSciences Corporation · 2007 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK191684 MoniTorr ICP External Drainage and Monitoring System, LimiTorr…Integra LifeSciences Corporation · 2019
- Descendant · cites it directly · 1 of its ownK983799 Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical…Medtronic PS Medical · 1999
- Descendant · 2 generations on · 0 of its ownK221694 External Drainage SystemJmed (Shenzhen) Technology Limited · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · cites it directly4descendants
- K072929Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020…Integra LifeSciences Corporation · 2007 · 2 generations on2descendants
- K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External…Integra LifeSciences Corporation · 2019 · cites it directly1descendant
- K983799Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System…Medtronic PS Medical · 1999 · cites it directly1descendant
- K221694External Drainage SystemJmed (Shenzhen) Technology Limited · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY | Clinical Neuro Systems, LLC | 1992 | — |
| +1 | K022554 | Monitorr Icp External CSF Drainage and Monitoring System | Integra Neurosciences | 2002 | Class I |
| +2 | K072929 | Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models… | Integra LifeSciences Corporation | 2007 | Class I |
| +1 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting… | Integra LifeSciences Corporation | 2019 | — |
| +1 | K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau… | Medtronic PS Medical | 1999 | — |
| +2 | K221694 | External Drainage System | Jmed (Shenzhen) Technology Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 1 |
| 2006 | 1 | 1 |
| 2007 | 1 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022554 | Monitorr Icp External CSF Drainage and Monitoring System Class I | 2002 | 4 |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External… | 2019 | 1 |
| K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System… | 1999 | 1 |
| K062599 | Monitorr Icp External Drainage and Monitoring Systems Class I | 2006 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class I | Z-1310-2019 | Device Design | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K062599Monitorr Icp External Drainage and Monitoring SystemsIntegra LifeSciences Corporation · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
- K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
- K072929Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030Integra LifeSciences Corporation · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K022554 (Integra Neurosciences, 2002) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K920156 · printed Nov 5, 2026
Cite this page
510(k) Report. “K920156: Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920156
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026