510(k) · Cleared
Recalled · Class II · 2016Contour-Flex Valve and Shunt System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences Implants S.A. · JXG Shunt, Central Nervous System And Components
Cleared on Dec 17, 2003 as substantially equivalent to K954285 (Radionics, Inc., 1996) after a 22-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954285 (1996). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954285 Contour Flex Valves (Regular & Small)Radionics, Inc. · 1996
- This deviceK033698 Contour-Flex Valve and Shunt SystemIntegra Neurosciences Implants S.A. · 2003
- Descendant · cites it directly · 2 of its ownK172006 Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK221918 ReFlow System MiniAnuncia Medical, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK093968 Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK223603 Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK140722 Integra Flow Regulating Valve Systems Osv II Models and Integra Flow…Integra LifeSciences Corporation · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172006Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc. · 2017 · cites it directly2descendants
- K221918ReFlow System MiniAnuncia Medical, Inc. · 2022 · 2 generations on1descendant
- K093968Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010 · cites it directly1descendant
- K223603Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. · 2022 · 3 generations on0descendants
- K140722Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve…Integra LifeSciences Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954285 | Contour Flex Valves (Regular & Small) | Radionics, Inc. | 1996 | — |
| 0 (this device) | K033698 | Contour-Flex Valve and Shunt System | Integra Neurosciences Implants S.A. | 2003 | — |
| +1 | K172006 | Alivio Ventricular Catheter and Flusher System (Alivio System) | Alcyone Lifesciences, Inc. | 2017 | — |
| +2 | K221918 | ReFlow System Mini | Anuncia Medical, Inc. | 2022 | — |
| +1 | K093968 | Osv II Low Flow Low Pro Valve | Integra LifeSciences Corporation | 2010 | — |
| +3 | K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | 2022 | — |
| +2 | K140722 | Integra Flow Regulating Valve Systems Osv II Models and Integra Flow… | Integra LifeSciences Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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? (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 | Decided |
|---|---|---|---|
| * | K954285 | Contour Flex Valves (Regular & Small)Summary page 1…ntour-Flex and Shunt System and the unmodified Contour-FlexTM Valve and Shunt System which has been cleared to market under Premarket Notification 510(k) K954285. Intended use: The Contour-FlexTM Valve and Shunt System is indicated for use in the treatment of patients with h… | 1996 |
| * | — | Contour-Flex and Shunt System Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2016 | Class II | Z-2905-2016 | Process control | During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K172006 (Alcyone Lifesciences, Inc., 2017) has gone furthest, with 2 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 | — |
What is it indicated for?
The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It is a component of a system designed to shunt cerebrospinal fluid fro the ventricles of the brain to an appropriate drainage site such as the atrium of the heart of to the peritoneal cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033698 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033698: Contour-Flex Valve and Shunt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033698
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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