510(k) · Cleared
ClearedCodman Lumbar Drainage Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Jun 25, 1997 as substantially equivalent to K855058 (Cordis Corp., 1986) after a 198-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Jun 25, 1997
- Review
- 198 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K855058 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK855058 Evds, Evmds, LDS & Ivmcs Central Nervous Sys FluidCordis Corp. · 1986 · Recalled
- This deviceK964923 Codman Lumbar Drainage Catheter KitJohnson & Johnson Professionals, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK242974 External CSF Drainage Ventricular Catheters, External CSF Drainage…Sophysa · 2025
- Descendant · cites it directly · 0 of its ownK021196 Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model…Neuron Therapeutics, Inc. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K855058 | Evds, Evmds, LDS & Ivmcs Central Nervous Sys Fluid | Cordis Corp. | 1986 | 1 |
| 0 (this device) | K964923 | Codman Lumbar Drainage Catheter Kit | Johnson & Johnson Professionals, Inc. | 1997 | — |
| +1 | K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar… | Sophysa | 2025 | — |
| +1 | K021196 | Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model PN1000735 | Neuron Therapeutics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K855058 | Evds, Evmds, LDS & Ivmcs Central Nervous Sys FluidSummary page 1…tial Equivalence The Lumbar Drainage Catheter Kit is substantially equivalent to the Cordis Lumbar Catheter Accessory Kit currently marketed in the United States under #K855058. The subject device is composed of similiar materials to the Cordis Lumbar Catheter Accessory Kit. Further, the intended use, de… | 1986 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 a recall.
- Of its descendants, K242974 (Sophysa, 2025) 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.
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 Lumbar Drainage Catheter Kit is indicated for temporary access to the lumbar subarachnoid region and, when used with other Codman devices, is designed to drain cerebrospinal fluid (CSF) as a means of reducing increased intracranial volume and pressure.
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/K964923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964923: Codman Lumbar Drainage Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964923
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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