510(k) · Cleared

Recalled · Class I · 2019

Monitorr Icp External Drainage and Monitoring Systems

K062599510(k) SpecialCleared Sep 27, 200626-day reviewClass II21 CFR 882.5550Recalls 2 (2 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Integra LifeSciences Corporation · JXG Shunt, Central Nervous System And Components

Cleared on Sep 27, 2006 as substantially equivalent to K920156 (Clinical Neuro Systems, LLC, 1992) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1992. 3 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including 2 Class I recalls.

Decided: Sep 27, 2006
Review: 26 days
Class: Class II
Product code: JXG
Recalls: 2 (2 Class I)
Predicates: 2

Its longest line of descent runs back 2 generations to K920156 (1992). No later device cites it as a predicate yet. 3 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

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 deviceK062599 Monitorr Icp External Drainage and Monitoring SystemsIntegra LifeSciences Corporation · 2006

Class I recalls in this family

K022554 Monitorr Icp External CSF Drainage and…direct predicate · 2002
K920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYdirect predicate · 1992

View 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)	K062599	Monitorr Icp External Drainage and Monitoring Systems	Integra LifeSciences Corporation	2006	—

FIG. 1 — Lineage of K062599, 1992–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K920156	Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY Summary page 1 …tended use to the unmodified MoniTorTM External CSF Drainage and Monitoring Systems which have been cleared to market under Premarket Notification 510(k)'s K920156 and K022554. Intended use: The MoniTorr ICPTM External CSF Drainage and Monitoring Systems allow for drainage and…	Clinical Neuro Systems, LLC	1992	Class I
*	K022554	Monitorr Icp External CSF Drainage and Monitoring System Summary page 1 …o the unmodified MoniTorTM External CSF Drainage and Monitoring Systems which have been cleared to market under Premarket Notification 510(k)'s K920156 and K022554. Intended use: The MoniTorr ICPTM External CSF Drainage and Monitoring Systems allow for drainage and monitoring o…	Integra Neurosciences	2002	Class I

Also cleared against K920156: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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-1311-2019	Device Design	The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
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.

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 14 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.
3 other devices also cite its predicate K920156.

How does its category compare?

All JXG devices

JXG 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

2007high 8 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXG

255in 2025

2007high 276 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JXG

3in 2024

2007high 30 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXG

1,198in 2025

2007high 1,484 (2018) · low 629 (2009)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 MoniTorr ICP™ External CSF 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/K062599 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062599: Monitorr Icp External Drainage and Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062599

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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