510(k) · Cleared
Recalled · 2011Heyer-Schulte Syringo Peritoneal Shunt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American V. Mueller · JXG Shunt, Central Nervous System And Components
Cleared on Nov 27, 1985 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 5 times.
- Decided
- Nov 27, 1985
- Review
- 55 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 5
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2011 | Not classified | Z-1047-201 | Labeling mix-ups | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
| Nov 28, 2011 | Not classified | Z-1051-2012 | Labeling mix-ups | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
| Nov 28, 2011 | Not classified | Z-1049-2012 | Labeling mix-ups | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
| Nov 28, 2011 | Not classified | Z-1048-2012 | Labeling mix-ups | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
| Nov 28, 2011 | Not classified | Z-1050-2012 | Labeling mix-ups | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
No ancestor or descendant has a Class I 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.
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/K854049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K854049: Heyer-Schulte Syringo Peritoneal Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854049
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026