510(k) · Cleared
ClearedRadionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)
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 Mar 16, 1998 as substantially equivalent to K963577 (Radionics, Inc., 1996) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 1987. 108 later devices descend from it.
- Decided
- Mar 16, 1998
- Review
- 40 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K870028 (1987). 108 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 1 generation backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- This deviceK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- Descendant · cites it directly · 76 of its ownK021329 Rita SystemRita Medical Systems · 2002
- Descendant · 2 generations on · 75 of its ownK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- Descendant · 3 generations on · 56 of its ownK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- Descendant · 3 generations on · 50 of its ownK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- Descendant · 4 generations on · 42 of its ownK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K021329Rita SystemRita Medical Systems · 2002 · cites it directly76descendants
- K042216Cool-Tip RF Ablation SystemValleylab · 2004 · 2 generations on75descendants
- K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 3 generations on56descendants
- K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 3 generations on50descendants
- K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −1 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| 0 (this device) | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| +1 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| +2 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| +3 | K052796 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| +3 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| +4 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 11 | 0 |
| 2024 | 15 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K963577 | Radionics Sluijter-Mehta CannulaSummary page 2…cannula for radiofrequency electrode Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 1219140 William Rittman (781) 272-1233 Class I1 / Neurology RSM-C Cannula (K963577); SMK-C Cannula (K870028). The SC-C, RFK-DS and RFK-DB are intended for use in radiofrequency (RF) heat lesion procedures for re… | 1996 |
| * | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleSummary page 2…y electrode Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 1219140 William Rittman (781) 272-1233 Class I1 / Neurology RSM-C Cannula (K963577); SMK-C Cannula (K870028). The SC-C, RFK-DS and RFK-DB are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the… | 1987 |
What descends from it? (108)
See all 1087 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021329 | Rita System | 2002 | 76 |
| K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman… | 2005 | 20 |
| K034012 | Smith & Nephew RF Denervation Probes & RF Cannulae | 2004 | 15 |
| K021942 | Radionics Pole Needles | 2002 | 15 |
| K042375 | SMK, CX, Cxe, RCN | 2004 | 12 |
| K080771 | Top Neuropole Needle, Model SH, BL, SC, TC | 2008 | 4 |
| K041021 | RF Introduction Cannula | 2004 | 4 |
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 11 years and passes through 1 company; a new generation was cleared every 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021329 (Rita Medical Systems, 2002) has gone furthest, with 76 descendants of its own.
- 5 other devices also cite its predicate K963577.
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?
The SC-C, RFK-DS, and RFK-DB cannulae are indicated for use in RF heat lesion procedures
for the relief of pain.
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/K980430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980430
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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