510(k) · Cleared
ClearedMedtronic PS Medical External Drainage and Monitoring (Edm) Ventricular Catheter, 20CM and 35 CM Model # 96115 and 96118
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic PS Medical · JXG Shunt, Central Nervous System And Components
Cleared on Jun 16, 1998 as substantially equivalent to K902257 (Codman & Shurtleff, Inc., 1990) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 16, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902257 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- This deviceK981046 Medtronic PS Medical External Drainage and Monitoring (Edm)…Medtronic PS Medical · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| 0 (this device) | K981046 | Medtronic PS Medical External Drainage and Monitoring (Edm) Ventricular… | Medtronic PS Medical | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K902257 | Codman* External Drainage System II (Eds-II)Summary page 1…g (EDM) Ventricular Catheter w/BioGlide Common usual or Classification Name: Ventricular Catheter (882.4100) Predic ' ification: Codman External Drainage Catheter Set (K902257, K920938), Medtronic PS Medical Ventricular Catheter with BioGlide submitted under the Premarket Notification for the BioGlide Sh… | 1990 |
| * | K910938 | Codman External Drainage System II (Eds II) Our OCR of the scanned summary read K920938, FDA’s number for VJW2919 Pneumatic Compression Upgrade (Varian Canada, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman External Drainage Catheter Set”. | 1991 |
| * | K951258 | PS Medical Bioglide CSF-Flow Control Shunt KitSummary page 1…Drainage Catheter Set (K902257, K920938), Medtronic PS Medical Ventricular Catheter with BioGlide submitted under the Premarket Notification for the BioGlide Shunt Kit (K951258) Description: The Medtronic PS Medical EDM Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer… | 1995 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K902257.
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 | — |
What is it indicated for?
The EDM Ventricular Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain.
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/K981046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981046: Medtronic PS Medical External Drainage and Monitoring (Edm) Ventricular Catheter, 20CM and 35 CM Model # 96115 and 96118.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981046
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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