510(k) · Cleared
ClearedEqui-Flow Valve and Shunt System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences Implants S.A. · JXG Shunt, Central Nervous System And Components
Cleared on Oct 6, 2004 as substantially equivalent to K033698 (Integra Neurosciences Implants S.A., 2003) and 2 other predicates after a 15-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Oct 6, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954285 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954285 | Contour Flex Valves (Regular & Small) | Radionics, Inc. | 1996 | — |
| −1 | K033698 | Contour-Flex Valve and Shunt System | Integra Neurosciences Implants S.A. | 2003 | 1 |
| 0 (this device) | K042558 | Equi-Flow Valve and Shunt System | Integra Neurosciences Implants S.A. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K033698 | Contour-Flex Valve and Shunt SystemSummary page 1…antially equivalent in function and intended use to the currently marketed Equi-FlowTM Valve and Shunt System and Contour- Flex Valve and Shunt System 510K K033698 which have been cleared to market under Premarket Notifications 510(k)s K964386 and K971511. Intended use: The Equi… | 2003 |
| * | K964386 | Radionics Contour Flex Plus ValveSummary page 1…FlowTM Valve and Shunt System and Contour- Flex Valve and Shunt System 510K K033698 which have been cleared to market under Premarket Notifications 510(k)s K964386 and K971511. Intended use: The Equi-FlowTM Valve and Shunt System is indicated for use in the treatment of patients… | 1997 |
| * | K971511 | Radionics Contour Flex Valve, Radionics Contour Flex Plus ValveSummary page 1…and Shunt System and Contour- Flex Valve and Shunt System 510K K033698 which have been cleared to market under Premarket Notifications 510(k)s K964386 and K971511. Intended use: The Equi-FlowTM Valve and Shunt System is indicated for use in the treatment of patients with hydroc… | 1997 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K033698.
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 Equi-FlowTM Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.
The Equi-FlowTM Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the Distal Catheter of the shunt system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042558: Equi-Flow Valve and Shunt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042558
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