510(k) · Cleared
ClearedNeuro N 50 Lesion Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leibinger & Fischer, Ltd. · GXD Generator, Lesion, Radiofrequency
Cleared on Mar 19, 1991 after a 495-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Mar 19, 1991
- Review
- 495 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK896450 Neuro N 50 Lesion GeneratorLeibinger & Fischer, Ltd. · 1991
- Descendant · cites it directly · 17 of its ownK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- Descendant · 2 generations on · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
- Descendant · cites it directly · 5 of its ownK070336 Stockert Neuro N50, MODEL12267Stockert GmbH · 2007
- Descendant · 2 generations on · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- Descendant · 3 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005 · cites it directly17descendants
- K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · 2 generations on7descendants
- K070336Stockert Neuro N50, MODEL12267Stockert GmbH · 2007 · cites it directly5descendants
- K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · 2 generations on5descendants
- K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896450 | Neuro N 50 Lesion Generator | Leibinger & Fischer, Ltd. | 1991 | — |
| +1 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| +2 | K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016 | — |
| +1 | K070336 | Stockert Neuro N50, MODEL12267 | Stockert GmbH | 2007 | — |
| +2 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| +3 | K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 202 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?
- Of its descendants, K043442 (Stryker Instruments, 2005) has gone furthest, with 17 descendants of its own.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K896450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896450: Neuro N 50 Lesion Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896450
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026