510(k) · Cleared
ClearedStockert Neuro N50, MODEL12267
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stockert GmbH · GXD Generator, Lesion, Radiofrequency
Cleared on Jun 14, 2007 as substantially equivalent to K896450 (Leibinger & Fischer, Ltd., 1991) after a 129-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Jun 14, 2007
- Review
- 129 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896450 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK896450 Neuro N 50 Lesion GeneratorLeibinger & Fischer, Ltd. · 1991
- This deviceK070336 Stockert Neuro N50, MODEL12267Stockert GmbH · 2007
- Descendant · cites it directly · 4 of its ownK171143 Relievant Medsystems RF GeneratorRelievant Medsystems · 2017
- Descendant · 2 generations on · 3 of its ownK190504 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept…Relievant Medsystems · 2019
- Descendant · 3 generations on · 1 of its ownK213836 Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK250213 OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single…Stryker Instruments · 2025
- Descendant · 4 generations on · 0 of its ownK222281 Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K171143Relievant Medsystems RF GeneratorRelievant Medsystems · 2017 · cites it directly4descendants
- K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve…Relievant Medsystems · 2019 · 2 generations on3descendants
- K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · 3 generations on1descendant
- K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…Stryker Instruments · 2025 · 3 generations on0descendants
- K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896450 | Neuro N 50 Lesion Generator | Leibinger & Fischer, Ltd. | 1991 | — |
| 0 (this device) | K070336 | Stockert Neuro N50, MODEL12267 | Stockert GmbH | 2007 | — |
| +1 | K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | 2017 | — |
| +2 | K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept… | Relievant Medsystems | 2019 | — |
| +3 | K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022 | — |
| +3 | K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)… | Stryker Instruments | 2025 | — |
| +4 | K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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 GXD? 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 GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 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 |
|---|---|---|---|
| * | K896450 | Neuro N 50 Lesion GeneratorSummary page 1…21 CFR 882.4400, Product Code GXD, Class II Predicate Device: NEURO N 50 LESION GENERATOR 510(k) No. K896450 Description: The system consists of a radio frequency generator and accessories… | 1991 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171143 | Relievant Medsystems RF Generator | 2017 | 4 |
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?
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, 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 | 4 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Stockert NEURO N5b is a RF generator for general high frequency applications:
1. Lesioning nerve tissue for functional neurosurgical procedures; or
2. Radiofrequency heat lesion procedures for the relief of pain; or
3. Stimulation procedures like provoking stimulation, localized stimulation, blocking stimulation or intraoperative test stimulation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070336: Stockert Neuro N50, MODEL12267.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070336
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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