510(k) · Cleared
ClearedOsv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · JXG Shunt, Central Nervous System And Components
Cleared on Nov 19, 2009 as substantially equivalent to K971799 (Elekta Implants, SA, 1998) and 3 other predicates after a 106-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Nov 19, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K913636 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK913636 Orbis-Sigma Valve System for Ventricular ShuntingCordis Corp. · 1991
- 2 generations backK971799 Precision Flow Osv IIElekta Implants, SA · 1998
- 1 generation backK042192 Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A. · 2004
- This deviceK092395 Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009
- Descendant · cites it directly · 0 of its ownK140722 Integra Flow Regulating Valve Systems Osv II Models and Integra Flow…Integra LifeSciences Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K140722Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve…Integra LifeSciences Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913636 | Orbis-Sigma Valve System for Ventricular Shunting | Cordis Corp. | 1991 | — |
| −2 | K971799 | Precision Flow Osv II | Elekta Implants, SA | 1998 | — |
| −1 | K042192 | Low Flow Osv II Hydrocephalus Valve | Integra Neurosciences Implants S.A. | 2004 | — |
| 0 (this device) | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra Lifesciences Corp. | 2009 | — |
| +1 | K140722 | Integra Flow Regulating Valve Systems Osv II Models and Integra Flow… | Integra LifeSciences Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K971799 | Precision Flow Osv IISummary page 3…nd OSV II Low Flow Valves are substantially equivalent in function to the currently approved OSV II and Integra NPH Low Flow Valve Systems cleared to market by FDA under K971799, K081773, and K042192. This.bundled 510(k) supports the use of both valve systems using a lumbo-peritoneal approach. The accessor… | 1998 |
| * | K081773 | OSV IISummary page 3…Low Flow Valves are substantially equivalent in function to the currently approved OSV II and Integra NPH Low Flow Valve Systems cleared to market by FDA under K971799, K081773, and K042192. This.bundled 510(k) supports the use of both valve systems using a lumbo-peritoneal approach. The accessories provi… | 2008 |
| * | K042192 | Low Flow Osv II Hydrocephalus ValveSummary page 3…ves are substantially equivalent in function to the currently approved OSV II and Integra NPH Low Flow Valve Systems cleared to market by FDA under K971799, K081773, and K042192. This.bundled 510(k) supports the use of both valve systems using a lumbo-peritoneal approach. The accessories provided allow for… | 2004 |
| * | K944595 | Cordis Horizontal-Verical Valve SystemSummary page 3…rovided allow for a lumbar approach and are substantially equivalent to the accessories provided with the Integra H-V Lumbar Valve System, which was cleared by FDA under K944595 for the same intended use. These accessories include a 14G tuohy needle, F5 lumbar catheter, guidewire, stepdown connector, and s… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140722 | Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve… | 2015 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140722 (Integra LifeSciences Corporation, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K971799.
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?
The OSV II® Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.
The OSV II Low Flow Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092395: Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092395
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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