510(k) · Cleared
ClearedGemini Standard and Mini Valves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurocare Group · JXG Shunt, Central Nervous System And Components
Cleared on Mar 10, 1998 as substantially equivalent to K802586 (American Heyer Schulte, 1980) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.
- Decided
- Mar 10, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802586 (1980). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK802586 American Heyer-Schulte Low Profile ValveAmerican Heyer Schulte · 1980
- This deviceK974708 Gemini Standard and Mini ValvesNeurocare Group · 1998
- Descendant · cites it directly · 0 of its ownK153041 Bundled Neurological Shunts and Accessories Product Families…Integra LifeSciences Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to…Integra LifeSciences Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802586 | American Heyer-Schulte Low Profile Valve | American Heyer Schulte | 1980 | — |
| 0 (this device) | K974708 | Gemini Standard and Mini Valves | Neurocare Group | 1998 | — |
| +1 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling… | Integra LifeSciences Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K802586 | American Heyer-Schulte Low Profile ValveSummary page 1…alves are substantially equivalent to other CSF shunting valves currently marketed known as the Heyer-Schulte NeuroCare Low-Profile Valves (LPV, Mini-LPV and ProfileVS), K802586A, and the Heyer-Schulte NeuroCare NOVUS Standard and Mini Valves, K961859, with respect to the functionality, design, placement a… | 1980 |
| * | K961859 | Novus Standard and Pediatric ValvesSummary page 1…marketed known as the Heyer-Schulte NeuroCare Low-Profile Valves (LPV, Mini-LPV and ProfileVS), K802586A, and the Heyer-Schulte NeuroCare NOVUS Standard and Mini Valves, K961859, with respect to the functionality, design, placement and use in the neurosurgical arena. The Gemini Standard and Mini Valves a… | 1996 |
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 |
|---|---|---|---|
| K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to… | 2016 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K153041 (Integra LifeSciences Corporation, 2016) has gone furthest, with 0 descendants 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 | — |
What is it indicated for?
The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt
cerebrospinal fiuid (CSF) from the lateral ventricles of the brain into either the right
atrium of the heart or the peritoneal cavity.
This device should only be used by a physician or qualified personnel under the
direction of a physician.
Care must be taken to ensure compliance with the manufacturer’s instructions for use.
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/K974708 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974708: Gemini Standard and Mini Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974708
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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