510(k) · Cleared
ClearedPolaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB
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 Feb 26, 2004 as substantially equivalent to K013488 (Sophysa SA, 2002) after a 325-day review. Its family tree reaches back 4 generations to 1995. 8 later devices descend from it.
- Decided
- Feb 26, 2004
- Review
- 325 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944222 (1995). 5 ancestors in all, the oldest K861377 (1986). 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 3 generations backK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK992465 Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000
- 1 generation backK013488 Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002
- This deviceK031097 Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 2004
- Descendant · cites it directly · 7 of its ownK042481 Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300…Sophysa SA · 2004
- Descendant · 2 generations on · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK141687 Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K042481Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400Sophysa SA · 2004 · cites it directly7descendants
- K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · 2 generations on6descendants
- K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · 3 generations on4descendants
- K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015 · 3 generations on2descendants
- K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K974739 | Hakim Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K992465 | Sophy SU8 Pressure Adjustable Valve | Sophysa SA | 2000 | — |
| −1 | K013488 | Sophy Pressure Adjustable Valve System Model SM8 | Sophysa SA | 2002 | — |
| 0 (this device) | K031097 | Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB | Sophysa SA | 2004 | — |
| +1 | K042481 | Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400 | Sophysa SA | 2004 | — |
| +2 | K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | Aesculap, Inc. | 2007 | — |
| +3 | K103003 | Aesculap- Meithke Progav Programmable Shunt System | Aesculap, Inc. | 2010 | 5 |
| +3 | K141687 | Aesculap - Meithke Progav 2.0 Adjustable Shunt System | Aesculap, Inc. | 2015 | — |
| +3 | K120559 | Aesculap-Meithke Prosa Adjustable Shunt System | Aesculap, Inc. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K013488 | Sophy Pressure Adjustable Valve System Model SM8 | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042481 | Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400 | 2004 | 7 |
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 9 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K042481 (Sophysa SA, 2004) has gone furthest, with 7 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?
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031097: Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031097
Report an extraction error
Are you the manufacturer?
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