510(k) · Cleared
ClearedRadionics Microelectrode Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Sep 21, 1999 after a 152-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.
- Decided
- Sep 21, 1999
- Review
- 152 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK991399 Radionics Microelectrode KitRadionics, Inc. · 1999
- Descendant · cites it directly · 20 of its ownK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 10 of its ownK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK012850 Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 2001
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Cosman Medical, Inc. · 2005 · cites it directly20descendants
- K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006 · 2 generations on10descendants
- K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006 · 2 generations on9descendants
- K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008 · 2 generations on7descendants
- K012850Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 2001 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991399 | Radionics Microelectrode Kit | Radionics, Inc. | 1999 | — |
| +1 | K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit… | Cosman Medical, Inc. | 2005 | 3 |
| +2 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| +2 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| +2 | K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4 | Cosman Medical, Inc. | 2008 | — |
| +1 | K012850 | Recording and Stimulating Electrode | Radionics, A Division of Tyco Healthcare Group LP | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | TM electrodes Named without a submission number | |
| * | — | TCM electrodes Named without a submission number |
What descends from it? (28)
See all 282 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, K050084 (Cosman Medical, Inc., 2005) has gone furthest, with 20 descendants of its own.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991399: Radionics Microelectrode Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991399
Report an extraction error
Are you the manufacturer?
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