510(k) · Cleared
ClearedIntegra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models
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 6, 2015 as substantially equivalent to K042192 (Integra Neurosciences Implants S.A., 2004) and 3 other predicates after a 291-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jan 6, 2015
- Review
- 291 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K913636 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK913636 Orbis-Sigma Valve System for Ventricular ShuntingCordis Corp. · 1991
- 3 generations backK971799 Precision Flow Osv IIElekta Implants, SA · 1998
- 2 generations backK042192 Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A. · 2004
- 1 generation backK092395 Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009
- This deviceK140722 Integra Flow Regulating Valve Systems Osv II Models and Integra Flow…Integra LifeSciences Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913636 | Orbis-Sigma Valve System for Ventricular Shunting | Cordis Corp. | 1991 | — |
| −3 | K971799 | Precision Flow Osv II | Elekta Implants, SA | 1998 | — |
| −2 | K042192 | Low Flow Osv II Hydrocephalus Valve | Integra Neurosciences Implants S.A. | 2004 | — |
| −1 | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra Lifesciences Corp. | 2009 | — |
| 0 (this device) | 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 |
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K042192 | Low Flow Osv II Hydrocephalus ValveSummary page 4…ted device(s) to which equivalence is claimed Equivalence is claimed to current Integra Flow Regulating Valves cleared under the following Premarket Notifications: K042192 - Integra Flow Regulating Valve Low Flow (Standard) K081773 – OSV II and OSV II Low Pro K093968- Integra Flow Regulating Valv… | 2004 |
| * | K081773 | OSV IISummary page 4…claimed to current Integra Flow Regulating Valves cleared under the following Premarket Notifications: K042192 - Integra Flow Regulating Valve Low Flow (Standard) K081773 – OSV II and OSV II Low Pro K093968- Integra Flow Regulating Valve Low Flow (Mini) K092395 - OSV II Lumbar and Integra Flow R… | 2008 |
| * | K093968 | Osv II Low Flow Low Pro ValveSummary page 4…ating Valves cleared under the following Premarket Notifications: K042192 - Integra Flow Regulating Valve Low Flow (Standard) K081773 – OSV II and OSV II Low Pro K093968- Integra Flow Regulating Valve Low Flow (Mini) K092395 - OSV II Lumbar and Integra Flow Regulating Valve Low Flow (Lumbar) 80… | 2010 |
| * | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemSummary page 4…fications: K042192 - Integra Flow Regulating Valve Low Flow (Standard) K081773 – OSV II and OSV II Low Pro K093968- Integra Flow Regulating Valve Low Flow (Mini) K092395 - OSV II Lumbar and Integra Flow Regulating Valve Low Flow (Lumbar) 807.92(a)(4) - Device description The Integra Flow Regula… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 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. 2015, 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?
Models for ventricular application:
The Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with hydocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
Models for lumbar application:
The Lumbar Integra Flow Regulating Valve Systems are implantable systems 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/K140722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140722: Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140722
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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