510(k) · Cleared
ClearedSophy SU8 Pressure Adjustable Valve
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 Sep 21, 2000 as substantially equivalent to K974739 (Johnson & Johnson Professionals, Inc., 1998) and 1 other predicate after a 426-day review. Its family tree reaches back 2 generations to 1995. 1 of the 33 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Sep 21, 2000
- Review
- 426 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944222 (1995). 3 ancestors in all, the oldest K861377 (1986). 29 later devices descend from it, 2 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 1 generation backK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- This deviceK992465 Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000
- Descendant · cites it directly · 25 of its ownK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- Descendant · 2 generations on · 23 of its ownK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- Descendant · 2 generations on · 19 of its ownK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- Descendant · cites it directly · 9 of its ownK013488 Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002
- Descendant · 2 generations on · 8 of its ownK031097 Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 2004
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K152700 StrataMR Valves and Shunts3 generations on · 2016
Most influential descendants
Showing 5 of 29 · See all- K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002 · cites it directly25descendants
- K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery · 2004 · 2 generations on23descendants
- K042465PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · 2 generations on19descendants
- K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002 · cites it directly9descendants
- K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 2004 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −1 | K974739 | Hakim Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| 0 (this device) | K992465 | Sophy SU8 Pressure Adjustable Valve | Sophysa SA | 2000 | — |
| +1 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| +2 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| +2 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| +1 | K013488 | Sophy Pressure Adjustable Valve System Model SM8 | Sophysa SA | 2002 | — |
| +2 | K031097 | Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB | Sophysa SA | 2004 | — |
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 |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K974739 | Hakim Programmable Valve SystemSummary page 1…te Device(s) The Sophy® SUS8 is substantially'equivalent to the following previously cleared and currently marketing devices Johnson & Johnson Hakim Programmable Valve (K974739) and Cordis Standard/Pediatric Valve (K861377). D. Device Description The Sophy® Pressure Adjustable Valve System SU8 is an imp… | 1998 |
| * | K861377 | Standard/Pediatric Cordis Hydrocephalus ValvesSummary page 1…'equivalent to the following previously cleared and currently marketing devices Johnson & Johnson Hakim Programmable Valve (K974739) and Cordis Standard/Pediatric Valve (K861377). D. Device Description The Sophy® Pressure Adjustable Valve System SU8 is an implantable device designed for the treatment of… | 1986 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K012052 (Medtronic PS Medical, 2002) has gone furthest, with 25 descendants of its own.
- 9 other devices also cite its predicate K974739.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992465: Sophy SU8 Pressure Adjustable Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992465
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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