510(k) · Cleared
ClearedPolaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400
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 Aug 11, 2009 after a 182-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Aug 11, 2009
- Review
- 182 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK090342 Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140…Sophysa SA · 2009
- Descendant · cites it directly · 3 of its ownK112156 Codman Certas Programmable Valve System, Codman Certas Therapy…Medos International SARL · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK143111 Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL · 2015
- Descendant · 3 generations on · 0 of its ownK181902 Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp. · 2018
- Descendant · 2 generations on · 0 of its ownK113526 Codman Certas Programmable Valve SystemMedos International SARL · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K112156Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemMedos International SARL · 2011 · cites it directly3descendants
- K143111Codman Certas Plus Programmable Valve; Codman Certas Toll KitMedos International SARL · 2015 · 2 generations on1descendant
- K181902Codman Certas Plus Electronic Tool KitIntegra Lifesciences Corp. · 2018 · 3 generations on0descendants
- K113526Codman Certas Programmable Valve SystemMedos International SARL · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090342 | Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300… | Sophysa SA | 2009 | — |
| +1 | K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | Medos International SARL | 2011 | 16 |
| +2 | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | Medos International SARL | 2015 | — |
| +3 | K181902 | Codman Certas Plus Electronic Tool Kit | Integra Lifesciences Corp. | 2018 | — |
| +2 | K113526 | Codman Certas Programmable Valve System | Medos International SARL | 2012 | 16 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | 2011 | 3 |
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, K112156 (Medos International SARL, 2011) has gone furthest, with 3 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. 2009, 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?
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090342: Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090342
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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