510(k) · Cleared
ClearedOneRF Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuroone Medical Technologies Corp. · GXD Generator, Lesion, Radiofrequency
Cleared on Dec 6, 2023 as substantially equivalent to K082051 (Cosman Medical, Inc., 2008) and 1 other predicate after a 181-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Dec 6, 2023
- Review
- 181 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K870028 (1987). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 4 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 3 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 2 generations backK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
- 1 generation backK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
- This deviceK231675 OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
- Descendant · cites it directly · 0 of its ownK251243 OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −4 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −3 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −2 | K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit… | Cosman Medical, Inc. | 2005 | 3 |
| −1 | K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4 | Cosman Medical, Inc. | 2008 | — |
| 0 (this device) | K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | 2023 | — |
| +1 | K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4Summary page 6…requency Lesion Generator as our primary predicate device; specifically, the Cosman G4 Radiofrequency Generator that received marketing authorization after FDA review of K082051 and was cleared under 21 CFR 882.4400 (product code GXD). This RF Generator was chosen as the primary predicate because it has th… | 2008 |
| * | K010202 | Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion ProbesSummary page 6…osen as RF lesions can only be created with a RF Generator and RF Probe. This device is the Diros OWL RF Probe which received marketing authorization after FDA review of K010202 and was cleared under 21 CFR 882.4725 (product code GXI). To create an RF Ablation System this RF Probe was chosen as an addition… | 2001 |
| † | K211367 | Evo sEEG System | 2021 |
| † | K222404 | Evo® sEEG System | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | 2025 | 0 |
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 36 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K251243 (Neuroone Medical Technologies Corp., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082051.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231675: OneRF Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231675
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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