510(k) · Cleared
ClearedShuntcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurodx Development, LLC · JXG Shunt, Central Nervous System And Components
Cleared on Mar 7, 2013 as substantially equivalent to K080168 (Neuro Diagnostic Devices, 2008) after a 108-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Mar 7, 2013
- Review
- 108 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080168 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK080168 Shuntcheck - CSF Shunt Flow DetectorNeuro Diagnostic Devices · 2008
- This deviceK123554 ShuntcheckNeurodx Development, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080168 | Shuntcheck - CSF Shunt Flow Detector | Neuro Diagnostic Devices | 2008 | — |
| 0 (this device) | K123554 | Shuntcheck | Neurodx Development, LLC | 2013 | — |
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? (1)
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 |
|---|---|---|---|
| * | K080168 | Shuntcheck - CSF Shunt Flow DetectorSummary page 1…": The proposed device, ShuntCheck Ill is substantially equivalent to its predicate, ShuntCheck v2.2 (K080168) by virtue of a common indication for use and similar technical characteristics. Performance test results confirm that ShuntCheck… | 2008 |
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?
- Its one ancestor has no recall.
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. 2013, 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?
ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts. ShuntCheck includes Micro-Pumper, a component which may be used to temporarily increase CSF flow in suspected non-flowing, patent shunts during the ShuntCheck test. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123554: Shuntcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123554
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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