510(k) · Cleared
ClearedNimbus Electrosurgical Radiofrequency Multitined Expandable Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerics · GXI Probe, Radiofrequency Lesion
Cleared on Sep 21, 2012 as substantially equivalent to K972846 (Baylis Medical Co., Inc., 1998) after a 95-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Sep 21, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972846 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972846 BMC RF CannulaBaylis Medical Co., Inc. · 1998 · Recalled
- This deviceK121773 Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeBiomerics · 2012
- Descendant · cites it directly · 0 of its ownK190259 Vesta RF CannulaBiomerics · 2020
- Descendant · cites it directly · 0 of its ownK150371 Diros OWL Sterile Single Use TridentTM R.F. Insulated…Diros Technology, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972846 | BMC RF Cannula | Baylis Medical Co., Inc. | 1998 | 2 |
| 0 (this device) | K121773 | Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode | Biomerics | 2012 | — |
| +1 | K190259 | Vesta RF Cannula | Biomerics | 2020 | — |
| +1 | K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and… | Diros Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 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 GXI? 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 GXI device
- #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 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 |
|---|---|---|---|
| * | K972846 | BMC RF CannulaSummary page 2…diofrequency Multitined Expandable Electrode Predicate Device: 510(k) No. Trade Name. Manufacturer KK972846 BMC RE Cannula Baylis Medical Cornpany Inc. Device Description: The NIMBUS Electrosurgical… | 1998 |
What descends from it? (2)
2 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?
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXI
183in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXI
98in 2025
MAUDE reports naming product code GXI, 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 | 87 | 3 | 1 |
| 2008 | 2 | — | 1 | 4 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 2 | — | 1 | 8 |
| 2011 | 3 | 64 | 0 | 5 |
| 2012 | 1 | — | 1 | 14 |
| 2013 | 1 | — | 1 | 25 |
| 2014 | 1 | — | 0 | 20 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 3 | 240 | 0 | 16 |
| 2017 | 3 | 125 | 1 | 150 |
| 2018 | 1 | — | 0 | 147 |
| 2019 | 3 | 63 | 1 | 93 |
| 2020 | 3 | 255 | 0 | 31 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 2 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 4 | 183 | 0 | 98 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode, in combination with an RF generator and probe, are intended for use in madiofrequency (RF) heat lesion procedures for relief of pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121773: Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121773
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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