510(k) · Cleared
ClearedNovus Standard and Pediatric Valves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurocare, LLC · JXG Shunt, Central Nervous System And Components
Cleared on Dec 16, 1996 after a 216-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 16, 1996
- Review
- 216 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK961859 Novus Standard and Pediatric ValvesIntegra Neurocare, LLC · 1996
- Descendant · cites it directly · 2 of its ownK020728 Miethke Shunt SystemAesculap, Inc. · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK974708 Gemini Standard and Mini ValvesNeurocare Group · 1998
- Descendant · 2 generations on · 0 of its ownK242003 XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK200950 Ventricular CatheterAesculap, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK153041 Bundled Neurological Shunts and Accessories Product Families…Integra LifeSciences Corporation · 2016
Most influential descendants
Showing 5 of 5 · See all- K020728Miethke Shunt SystemAesculap, Inc. · 2002 · cites it directly2descendants
- K974708Gemini Standard and Mini ValvesNeurocare Group · 1998 · cites it directly1descendant
- K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024 · 2 generations on0descendants
- K200950Ventricular CatheterAesculap, Inc. · 2020 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K961859 | Novus Standard and Pediatric Valves | Integra Neurocare, LLC | 1996 | — |
| +1 | K020728 | Miethke Shunt System | Aesculap, Inc. | 2002 | 1 |
| +1 | K974708 | Gemini Standard and Mini Valves | Neurocare Group | 1998 | — |
| +2 | K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. | 2024 | — |
| +2 | K200950 | Ventricular Catheter | Aesculap, Inc. | 2020 | — |
| +1 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling… | Integra LifeSciences Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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?
- Of its descendants, K020728 (Aesculap, Inc., 2002) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K961859 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961859: Novus Standard and Pediatric Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961859
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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