510(k) · Cleared
ClearedExternal CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sophysa · JXG Shunt, Central Nervous System And Components
Cleared on Jun 20, 2025 as substantially equivalent to K853365 (Holter-Hausner Intl., 1985) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Jun 20, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K855058 (1986). 3 ancestors in all, the oldest K853365 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK855058 Evds, Evmds, LDS & Ivmcs Central Nervous Sys FluidCordis Corp. · 1986 · Recalled
- 1 generation backK964923 Codman Lumbar Drainage Catheter KitJohnson & Johnson Professionals, Inc. · 1997
- This deviceK242974 External CSF Drainage Ventricular Catheters, External CSF Drainage…Sophysa · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K855058 | Evds, Evmds, LDS & Ivmcs Central Nervous Sys Fluid | Cordis Corp. | 1986 | 1 |
| −1 | K964923 | Codman Lumbar Drainage Catheter Kit | Johnson & Johnson Professionals, Inc. | 1997 | — |
| 0 (this device) | K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar… | Sophysa | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 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 |
|---|---|---|---|
| * | K853365 | H-H Fifth VentricleSummary page 5…Device Class: 2 Product Code: JXG Predicate Device Predicate: Phoenix Neuro Catheters FVPC2 and FVPC4, Sophysa (K853365) Lumbar Drainage Catheter Kit, Codman (K964923) Device Description The Sophysa external CSF dra… | 1985 |
| * | K964923 | Codman Lumbar Drainage Catheter KitSummary page 5…Device Predicate: Phoenix Neuro Catheters FVPC2 and FVPC4, Sophysa (K853365) Lumbar Drainage Catheter Kit, Codman (K964923) Device Description The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF),… | 1997 |
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?
- The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 28.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K853365.
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. 2025, 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 Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242974: External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242974
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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