510(k) · Cleared
ClearedPolaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sophysa SA · JXG Shunt, Central Nervous System And Components
Cleared on Apr 2, 2015 after a 325-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Apr 2, 2015
- Review
- 325 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK141227 Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve…Sophysa SA · 2015
- Descendant · cites it directly · 0 of its ownK250636 Sophy Mini Monopressure Valve (SM1)Sophysa · 2025
- Descendant · cites it directly · 0 of its ownK222422 Polaris Valve Electronic Reading InstrumentSophysa · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141227 | Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx | Sophysa SA | 2015 | — |
| +1 | K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | 2025 | — |
| +1 | K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K250636 (Sophysa, 2025) has gone furthest, with 0 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. 2015, 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?
The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K141227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141227: Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141227
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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