510(k) · Cleared
ClearedOsv II Low Flow Low Pro Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · JXG Shunt, Central Nervous System And Components
Cleared on Jan 22, 2010 as substantially equivalent to K042192 (Integra Neurosciences Implants S.A., 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jan 22, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
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 deviceK093968 Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010
- 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) | K093968 | Osv II Low Flow Low Pro Valve | Integra LifeSciences Corporation | 2010 | — |
| +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 |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K042192 | Low Flow Osv II Hydrocephalus ValveSummary page 2…is substantially equivalent to the currently marketed NPH Valve, which was cleared to market by the United States Food and Drug Administration on September 2, 2004 under K042192. The only differences between the proposed valve and the NPH Valve are the silicone boot (external envelope) and the needle stop.… | 2004 |
| * | K033698 | Contour-Flex Valve and Shunt SystemSummary page 2…stop, which is substantially equivalent to the needle stop used in the currently marketed Contour- Flex Valve System cleared to market by FDA on December 17, 2003 under K033698. The proposed OSV II LFLP Valve and the NPH Valve are identical in principal of operation, performance specifications, materials… | 2003 |
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 19 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K140722 (Integra LifeSciences Corporation, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042192.
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. 2010, 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 Low Flow Low Pro Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093968: Osv II Low Flow Low Pro Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093968
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