510(k) · Cleared

Cleared

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System

K191684510(k) TraditionalCleared Oct 11, 2019109-day reviewClass II21 CFR 882.5550

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 Oct 11, 2019 as substantially equivalent to K920156 (Clinical Neuro Systems, LLC, 1992) and 2 other predicates after a 109-day review. Its family tree reaches back 3 generations to 1992. 3 of the 5 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Oct 11, 2019
Review: 109 days
Class: Class II
Product code: JXG
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K920156 (1992). 1 later device descends from it, 1 citing it directly. 3 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · Recalled (Class I)
2 generations backK022554 Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · Recalled (Class I)
1 generation backK072929 Limitorr Volume Limiting External CSF Drainage and Monitoring…Integra LifeSciences Corporation · 2007 · Recalled (Class I)
This deviceK191684 MoniTorr ICP External Drainage and Monitoring System, LimiTorr…Integra LifeSciences Corporation · 2019
Descendant · cites it directly · 0 of its ownK221694 External Drainage SystemJmed (Shenzhen) Technology Limited · 2023

Class I recalls in this family

K072929 Limitorr Volume Limiting External CSF Drainage…direct predicate · 2007
K022554 Monitorr Icp External CSF Drainage and…direct predicate · 2002
K920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYdirect predicate · 1992

Most influential descendants

Showing 1 of 1 · See all

K221694External Drainage SystemJmed (Shenzhen) Technology Limited · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K920156	Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY	Clinical Neuro Systems, LLC	1992	Class I
−2	K022554	Monitorr Icp External CSF Drainage and Monitoring System	Integra Neurosciences	2002	Class I
−1	K072929	Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models…	Integra LifeSciences Corporation	2007	Class I
0 (this device)	K191684	MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting…	Integra LifeSciences Corporation	2019	—
+1	K221694	External Drainage System	Jmed (Shenzhen) Technology Limited	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K191684, 1992–2023Source: 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? (3)

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 4 …JXG 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed MoniTorr ICP™ External Drainage and Monitoring Systems; K920156 / K022554 LimiTorr™ Volume Limiting External CSF Drainage Systems; K072929…	Clinical Neuro Systems, LLC	1992	Class I
*	K022554	Monitorr Icp External CSF Drainage and Monitoring System Summary page 4 …JXG 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed MoniTorr ICP™ External Drainage and Monitoring Systems; K920156 / K022554 LimiTorr™ Volume Limiting External CSF Drainage Systems; K072929…	Integra Neurosciences	2002	Class I
*	K072929	Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020… Summary page 4 …which equivalence is claimed MoniTorr ICP™ External Drainage and Monitoring Systems; K920156 / K022554 LimiTorr™ Volume Limiting External CSF Drainage Systems; K072929 3DJHRI ,QWH…	Integra LifeSciences Corporation	2007	Class I

Also cleared against K920156: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K221694	External Drainage System	Jmed (Shenzhen) Technology Limited	2023	0

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

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.

K072929Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030Integra LifeSciences Corporation · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
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 27 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
3 of the 3 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K221694 (Jmed (Shenzhen) Technology Limited, 2023) has gone furthest, with 0 descendants of its own.
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. 2019, this device’s year, is highlighted.

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™ system allows 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 the monitoring of ICP.

The LimiTorr™ system allows 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/K191684 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191684: MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191684

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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