510(k) · Cleared
ClearedBundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
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 Mar 14, 2016 as substantially equivalent to K974708 (Neurocare Group, 1998) and 8 other predicates after a 147-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Mar 14, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 2 generations to K802586 (1980). 10 ancestors in all, the oldest K760501 (1976). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802586 | American Heyer-Schulte Low Profile Valve | American Heyer Schulte | 1980 | — |
| −1 | K974708 | Gemini Standard and Mini Valves | Neurocare Group | 1998 | — |
| 0 (this device) | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling… | Integra LifeSciences Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 4 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 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.
Planning a device in JXG? 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? (19)
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 |
|---|---|---|---|
| * | K974708 | Gemini Standard and Mini ValvesSummary page 6…which equivalence is claimed Equivalence is claimed to current Integra Neurological Shunts and Accessories Products, as identified below: LPV II Valves and Kits - K974708 Novus Valves and Kits - K961859 Multi-Purpose Valve - Pre-amendment device Mishler Dual Chamber Valve with Integr… | 1998 |
| * | K961859 | Novus Standard and Pediatric ValvesSummary page 7…aimed to current Integra Neurological Shunts and Accessories Products, as identified below: LPV II Valves and Kits - K974708 Novus Valves and Kits - K961859 Multi-Purpose Valve - Pre-amendment device Mishler Dual Chamber Valve with Integral Connectors - K760784 Pudenz Flushing Valve wi… | 1996 |
| * | K760784 | Mishler 2 Chamb Flushing Valve,StandSummary page 7…alves and Kits - K974708 Novus Valves and Kits - K961859 Multi-Purpose Valve - Pre-amendment device Mishler Dual Chamber Valve with Integral Connectors - K760784 Pudenz Flushing Valve with Integral Connectors - K760501, K760502 Ultra VS In-Line Valve System – K894072 Pudenz Cardiac and Infa… | 1976 |
| * | K760501 | Valve, Standard Model Pudenze FlushingSummary page 7…Kits - K961859 Multi-Purpose Valve - Pre-amendment device Mishler Dual Chamber Valve with Integral Connectors - K760784 Pudenz Flushing Valve with Integral Connectors - K760501, K760502 Ultra VS In-Line Valve System – K894072 Pudenz Cardiac and Infant Catheter - Pre-amendment device Pudenz Ventricular Cat… | 1976 |
| * | K760502 | Valve, Anti-Syphon Model Pudenze Flush.Summary page 7…961859 Multi-Purpose Valve - Pre-amendment device Mishler Dual Chamber Valve with Integral Connectors - K760784 Pudenz Flushing Valve with Integral Connectors - K760501, K760502 Ultra VS In-Line Valve System – K894072 Pudenz Cardiac and Infant Catheter - Pre-amendment device Pudenz Ventricular Catheter - P… | 1976 |
| * | K894072 | The Pudenz in Line ValveSummary page 7…nt device Mishler Dual Chamber Valve with Integral Connectors - K760784 Pudenz Flushing Valve with Integral Connectors - K760501, K760502 Ultra VS In-Line Valve System – K894072 Pudenz Cardiac and Infant Catheter - Pre-amendment device Pudenz Ventricular Catheter - Pre-amendment device Pudenz Peritoneal Ca… | 1989 |
| * | K971617 | Endoscopic Ventricular CatheterSummary page 7…ol Catheter – K894072 Peritoneal Open-Ended Catheter With Slits – K894072 Portnoy Ventricular Catheter – Pre-amendment device Neuroview Endoscopic Ventricular Catheter – K971617 Integra CSF Reservoir with Integral Connectors - Pre-amendment device Essential Shunt Kit Burr Hole Design - K973525 Essential Sh… | 1997 |
| * | K973525 | Maurice Worldwide Shunt SystemSummary page 7…t device Neuroview Endoscopic Ventricular Catheter – K971617 Integra CSF Reservoir with Integral Connectors - Pre-amendment device Essential Shunt Kit Burr Hole Design - K973525 Essential Shunt Kit Flat Bottom Design – K973525 Connectors for Neurosurgical Use - Pre-amendment device On-Off Flushing Reservoi… | 1997 |
| * | K760785 | Mishler 2 Chamb Flushing Valve,Anti-SyphSummary page 7…e On-Off Flushing Reservoirs - Pre-amendment device Braden Flushing Reservoir - Pre-amendment device Foltz Flushing Reservoir - Pre-amendment device Anti-Siphon Device – K760785 807.92(a)(4) - Device description Integra Neurological Shunts and Accessories are used in the treatment of hydrocephalus. Hydroc… | 1976 |
| * | — | Multi-Purpose Valve Named without a submission number | |
| * | — | Pudenz Cardiac and Infant Catheter Named without a submission number | |
| * | — | Pudenz Ventricular Catheter Named without a submission number | |
| * | — | Pudenz Peritoneal Catheter Named without a submission number | |
| * | — | Portnoy Ventricular Catheter Named without a submission number | |
| * | — | Integra CSF Reservoir with Integral Connectors Named without a submission number | |
| * | — | Connectors for Neurosurgical Use Named without a submission number | |
| * | — | On-Off Flushing Reservoirs Named without a submission number | |
| * | — | Braden Flushing Reservoir Named without a submission number | |
| * | — | Foltz Flushing Reservoir Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 18.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
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. 2016, 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?
LPV II Valves and Kits The Standard-LPV II and Mini-LPV II Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Mini-LPV II Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients. Novus Valves and Kits The Novus and…
Read the full statement (1,251 words)
LPV II Valves and Kits
The Standard-LPV II and Mini-LPV II Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Mini-LPV II Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.
Novus Valves and Kits
The Novus and Novus Mini Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Novus Mini Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients. Valves with a Physiological Flow Device are intended to reduce the hazard of negative intraventricular pressure (with respect to atmospheric pressure) when the patient is sitting, standing or semi-recumbent.
Multi-Purpose Valve
The Multi-Purpose Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Mishler Dual Chamber Valve with Integral Connectors
The Mishler Dual Chamber Flushing Valve, Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Pudenz Flushing Valve with Integral Connectors
The Pudenz Flushing Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Ultra VS In-Line Valve System
The Ultra VS In-Line Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles into either the peritoneal cavity or the right atrium of the heart. The in-line and burr-hole systems are designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneal cavity. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated. The Small and Neonate Models can be used in (but are not restricted to) situations where skin erosion may be a problem, as with premature infants, pediatric patients and older patients.
Pudenz Cardiac and Infant Catheter
The Pudenz Cardiac Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into the right atrium of the heart. The Infant Cardiac Catheter is utilized when the common facial and/or internal jugular veins are too small to accommodate the larger cardiac catheter.
Pudenz Ventricular Catheter
The Pudenz Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum.
Pudenz Peritoneal Catheter
The Pudenz Peritoneal Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.
Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits
The Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter with Slits, utilized in the treatment of hydrocephalic patients, are components for systems designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.
Portnoy Ventricular Catheter
The Portnoy Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Neuroview Endoscopic Ventricular Catheter
The Neuroview Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Integra CSF Reservoir with Integral Connectors
The Integra CSF Reservoir provides access to the lateral cerebral ventricles via hypodermic puncture for sampling and/or injection of fluids. It is useful in obtaining CSF samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The Convertible Integra CSF Reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Essential Shunt Kit Burr Hole Design
The CSF Control Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum.
Essential Shunt Kit Flat Bottom Design
The Essential Shunt Kit – Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The Essential Shunt Kit – Flat Bottom Design, can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.
Connectors for Neurosurgical Use
Integra connectors are utilized principally in the treatment of hydrocephalic patients, as components in systems designed to shunt cerebrospinal fluid from the lateral cerebral ventricles of the brain into either the right atrium of the heart or the peritoneum.
On-Off Flushing Reservoirs
The On-Off Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Reservoirs with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.
Braden Flushing Reservoir
The Braden Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Foltz Flushing Reservoir
The Foltz Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.
Anti-Siphon Device
The Anti-Siphon Device, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when the patient is in a sitting, standing or erect position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153041: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153041
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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