510(k) · Cleared
ClearedContour Flex Valves (Regular & Small)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Jan 26, 1996 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 26, 1996
- Review
- 134 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK954285 Contour Flex Valves (Regular & Small)Radionics, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK033698 Contour-Flex Valve and Shunt SystemIntegra Neurosciences Implants S.A. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK172006 Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK221918 ReFlow System MiniAnuncia Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK093968 Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010
- Descendant · 4 generations on · 0 of its ownK223603 Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K033698Contour-Flex Valve and Shunt SystemIntegra Neurosciences Implants S.A. · 2003 · cites it directly6descendants
- K172006Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc. · 2017 · 2 generations on2descendants
- K221918ReFlow System MiniAnuncia Medical, Inc. · 2022 · 3 generations on1descendant
- K093968Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010 · 2 generations on1descendant
- K223603Reflow System Mini and ReFlow Mini FlusherAnuncia Medical, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954285 | Contour Flex Valves (Regular & Small) | Radionics, Inc. | 1996 | — |
| +1 | K033698 | Contour-Flex Valve and Shunt System | Integra Neurosciences Implants S.A. | 2003 | 1 |
| +2 | K172006 | Alivio Ventricular Catheter and Flusher System (Alivio System) | Alcyone Lifesciences, Inc. | 2017 | — |
| +3 | K221918 | ReFlow System Mini | Anuncia Medical, Inc. | 2022 | — |
| +2 | K093968 | Osv II Low Flow Low Pro Valve | Integra LifeSciences Corporation | 2010 | — |
| +4 | K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033698 | Contour-Flex Valve and Shunt System | 2003 | 6 |
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?
- Of its descendants, K033698 (Integra Neurosciences Implants S.A., 2003) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K954285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954285: Contour Flex Valves (Regular & Small).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954285
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026