510(k) · Cleared
ClearedCordis Horizontal-Verical Valve System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · JXG Shunt, Central Nervous System And Components
Cleared on Oct 19, 1995 after a 395-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 19, 1995
- Review
- 395 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK944595 Cordis Horizontal-Verical Valve SystemCordis Corp. · 1995
- Descendant · cites it directly · 1 of its ownK101381 Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal…Integra LifeSciences Corporation · 2011
- 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 ownK161992 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal…Integra LifeSciences Corporation · 2016
- 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 4 of 4 · See all- K101381Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation · 2011 · cites it directly1descendant
- K092395Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp. · 2009 · cites it directly1descendant
- K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation · 2016 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K944595 | Cordis Horizontal-Verical Valve System | Cordis Corp. | 1995 | — |
| +1 | K101381 | Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems | Integra LifeSciences Corporation | 2011 | — |
| +1 | K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System | Integra Lifesciences Corp. | 2009 | — |
| +2 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt… | Integra LifeSciences Corporation | 2016 | — |
| +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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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?
- Of its descendants, K101381 (Integra LifeSciences Corporation, 2011) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K944595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944595: Cordis Horizontal-Verical 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/K944595
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026