510(k) · Cleared
ClearedRelievant Medsystems RF Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Relievant Medsystems · GXD Generator, Lesion, Radiofrequency
Cleared on Aug 18, 2017 as substantially equivalent to K070336 (Stockert GmbH, 2007) after a 122-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Aug 18, 2017
- Review
- 122 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896450 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK896450 Neuro N 50 Lesion GeneratorLeibinger & Fischer, Ltd. · 1991
- 1 generation backK070336 Stockert Neuro N50, MODEL12267Stockert GmbH · 2007
- This deviceK171143 Relievant Medsystems RF GeneratorRelievant Medsystems · 2017
- Descendant · cites it directly · 3 of its ownK190504 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept…Relievant Medsystems · 2019
- Descendant · 2 generations on · 1 of its ownK213836 Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK250213 OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single…Stryker Instruments · 2025
- Descendant · 3 generations on · 0 of its ownK222281 Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve…Relievant Medsystems · 2019 · cites it directly3descendants
- K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · 2 generations on1descendant
- K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…Stryker Instruments · 2025 · 2 generations on0descendants
- K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896450 | Neuro N 50 Lesion Generator | Leibinger & Fischer, Ltd. | 1991 | — |
| −1 | K070336 | Stockert Neuro N50, MODEL12267 | Stockert GmbH | 2007 | — |
| 0 (this device) | K171143 | Relievant Medsystems RF Generator | Relievant Medsystems | 2017 | — |
| +1 | K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept… | Relievant Medsystems | 2019 | — |
| +2 | K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022 | — |
| +2 | K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)… | Stryker Instruments | 2025 | — |
| +3 | K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070336 | Stockert Neuro N50, MODEL12267Summary page 4…assification Name: Radiofrequency lesion generator 21 CFR 882.4400, Product Code GXD Predicate Devices: Stockert NEURO N50 Generator: K070336 (primary) Relievant INTRACEPT Intraosseous Nerve Ablation System: K153272 (reference) Device Description: The Relievant RFG is a… | 2007 |
| † | K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | 2016 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve… | 2019 | 3 |
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 26 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190504 (Relievant Medsystems, 2019) has gone furthest, with 3 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. 2017, 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?
The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171143: Relievant Medsystems RF Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171143
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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