510(k) · Cleared
ClearedPrecision Flow Osv II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Implants, SA · JXG Shunt, Central Nervous System And Components
Cleared on Feb 6, 1998 as substantially equivalent to K913636 (Cordis Corp., 1991) after a 267-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Feb 6, 1998
- Review
- 267 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913636 (1991). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK913636 Orbis-Sigma Valve System for Ventricular ShuntingCordis Corp. · 1991
- This deviceK971799 Precision Flow Osv IIElekta Implants, SA · 1998
- Descendant · cites it directly · 3 of its ownK042192 Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A. · 2004
- Descendant · cites it directly · 2 of its ownK081773 OSV IIIntegra Neurosciences Implants S.A. · 2008
- Descendant · 2 generations on · 1 of its ownK093968 Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010
- Descendant · cites it directly · 1 of its ownK092395 Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK140722 Integra Flow Regulating Valve Systems Osv II Models and Integra Flow…Integra LifeSciences Corporation · 2015
Most influential descendants
Showing 5 of 5 · See all- K042192Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A. · 2004 · cites it directly3descendants
- K081773OSV IIIntegra Neurosciences Implants S.A. · 2008 · cites it directly2descendants
- K093968Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation · 2010 · 2 generations on1descendant
- K092395Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009 · cites it directly1descendant
- K140722Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve…Integra LifeSciences Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913636 | Orbis-Sigma Valve System for Ventricular Shunting | Cordis Corp. | 1991 | — |
| 0 (this device) | K971799 | Precision Flow Osv II | Elekta Implants, SA | 1998 | — |
| +1 | K042192 | Low Flow Osv II Hydrocephalus Valve | Integra Neurosciences Implants S.A. | 2004 | — |
| +1 | K081773 | OSV II | Integra Neurosciences Implants S.A. | 2008 | — |
| +2 | K093968 | Osv II Low Flow Low Pro Valve | Integra LifeSciences Corporation | 2010 | — |
| +1 | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra Lifesciences Corp. | 2009 | — |
| +2 | K140722 | Integra Flow Regulating Valve Systems Osv II Models and Integra Flow… | Integra LifeSciences Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K913636 | Orbis-Sigma Valve System for Ventricular ShuntingSummary page 2…13-226, 1987- attached to this section). This concept has been validated by clinical studies and use over more than seven years (Refer to the OSV Premarket Notification K913636 and Post-Market Surveillance report dated June 3, 1994). 8. Biocompatiblility The biocompatibility of the materials used in the… | 1991 |
| * | — | Cordis Omnishunt® System Named without a submission number | |
| * | — | Cordis Polypropylene Connectors Named without a submission number | |
| * | — | Cordis Ventricular Antechamber Named without a submission number | |
| * | — | Cordis Straight or Finned Ventricular Catheters (with radiopaque dots) Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
The Precision Flow OSV II 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971799: Precision Flow Osv II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971799
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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