510(k) · Cleared
ClearedNeuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model PN1000735
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuron Therapeutics, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Jul 1, 2002 as substantially equivalent to K964923 (Johnson & Johnson Professionals, Inc., 1997) after a 76-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Jul 1, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K855058 (1986). 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 deviceK021196 Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model…Neuron Therapeutics, Inc. · 2002
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) | K021196 | Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model PN1000735 | Neuron Therapeutics, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K964923 | Codman Lumbar Drainage Catheter KitSummary page 2…stantially equivalent to the CODMAN Lumbar External Drainage Catheter with Touhy Needle that is currently marketed in the United States under 5 1O(k) No. K964923. NTI’s 14-Gauge Lumbar Catheter and 14-Gauge Lumbar Puncture Set have the same intended use, design characteristi… | 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 16 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K964923.
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 Neuron Therapeutics Inc., 14-Gauge Lumbar Puncture Set is indicated for temporary access to the lumbar subarachnoid region to drain cerebrospinal fluid (CSF) and other fluids of similar physical characteristics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021196 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021196: Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model PN1000735.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021196
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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