510(k) · Cleared
ClearedVesta RF Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerics · GXI Probe, Radiofrequency Lesion
Cleared on Feb 7, 2020 as substantially equivalent to K121773 (Biomerics, 2012) after a 365-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Feb 7, 2020
- Review
- 365 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972846 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K121773 | Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeSummary page 4…Probe, Radiofrequency Lesion Classification Name: GXI – Radiofrequency Lesion Probe Premarket Notification: K121773 Manufacturer: Biomerics Per the FDA Medical Device Recalls Database,… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 14.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K121773.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190259: Vesta RF Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190259
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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