510(k) · Cleared
ClearedNeurocath AG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Neuro · JXG Shunt, Central Nervous System And Components
Cleared on Aug 12, 2008 as substantially equivalent to K800168 (Holter-Hausner Intl., 1980) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.
- Decided
- Aug 12, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K800168 (1980). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K170599SureFlo EVD CatheterArkis Biosciences, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800168 | H-H Fifth Ventricle | Holter-Hausner Intl. | 1980 | — |
| 0 (this device) | K081942 | Neurocath AG | Vygon Neuro | 2008 | — |
| +1 | K170599 | SureFlo EVD Catheter | Arkis Biosciences, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K800168 | H-H Fifth VentricleSummary page 1…hunt, Central Nervous System and. Components classif"atiom i.ass II Predicate Device Name: F fth Ventricle External Drainage Catheter (K800168/K.870(f0), Ex *meorft/real Ventricular Catheters (preamnendment) Device DesCription:… | 1980 |
| * | K853365 | H-H Fifth VentricleSummary page 2…971. Contw¢nsia The only change between the predicate device (Fifth Ventricle Drainage Catheter KH880/68 anod 1(853365) and the pt~aenncdnen prdiceate device and the Neurocath Ag is the chmnge in material… | 1985 |
| * | — | External Ventricular Catheters (preamendment) Named without a submission number |
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 |
|---|---|---|---|
| K170599 | SureFlo EVD Catheter | 2017 | 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, K170599 (Arkis Biosciences, Inc., 2017) 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. 2008, this device’s year, is highlighted.
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 Neurocath Ag catheter is designed to be temporarily implanted (less than 30 days) for the drainage of cerebrospinal fluid (CSF) to reduce and control increased intracranial pressure (ICP).
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/K081942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081942: Neurocath AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081942
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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