510(k) · Cleared
Recalled · Class I · 2019Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · JXG Shunt, Central Nervous System And Components
Cleared on Dec 7, 2007 as substantially equivalent to K022554 (Integra Neurosciences, 2002) after a 52-day review. Its family tree reaches back 2 generations to 1992. 3 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 7, 2007
- Review
- 52 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920156 (1992). 2 later devices descend from it, 1 citing it directly. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · Recalled (Class I)
- 1 generation backK022554 Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · Recalled (Class I)
- This deviceK072929 Limitorr Volume Limiting External CSF Drainage and Monitoring…Integra LifeSciences Corporation · 2007
- Descendant · cites it directly · 1 of its ownK191684 MoniTorr ICP External Drainage and Monitoring System, LimiTorr…Integra LifeSciences Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK221694 External Drainage SystemJmed (Shenzhen) Technology Limited · 2023
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY | Clinical Neuro Systems, LLC | 1992 | Class I |
| −1 | K022554 | Monitorr Icp External CSF Drainage and Monitoring System | Integra Neurosciences | 2002 | Class I |
| 0 (this device) | K072929 | Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models… | Integra LifeSciences Corporation | 2007 | — |
| +1 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting… | Integra LifeSciences Corporation | 2019 | — |
| +2 | K221694 | External Drainage System | Jmed (Shenzhen) Technology Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022554 | Monitorr Icp External CSF Drainage and Monitoring SystemSummary page 1…use to the unmodified MoniTorff~ External CSF Drainage and Monitoring Systems which have been cleared to market under Premarket Notification 5 10(k) K022554. Intended use: The LimiTorr"" Volume Limiting External CSF Drainage and Monitoring Systems allow for draina… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External… | 2019 | 1 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class I | Z-1312-2019 | 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.
- K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K920156Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K191684 (Integra LifeSciences Corporation, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K022554.
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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072929: Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072929
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026