510(k) · Cleared
ClearedRadionics Sluijter-Mehta Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Nov 21, 1996 as substantially equivalent to K870028 (Radionics, Inc., 1987) after a 76-day review. Its family tree reaches back 1 generation to 1987. 109 later devices descend from it.
- Decided
- Nov 21, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870028 (1987). 109 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- This deviceK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- Descendant · cites it directly · 108 of its ownK980430 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
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998 · cites it directly108descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| 0 (this device) | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleSummary page 1…Disposable cannula for radiofrequency electrode Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 1219140 Amy LaForte, Ph.D. (617) 272-1233 Class II SMK Cannula (K870028); and Radionics TIC Cannula (pre-amendment). The RSM-C is intended for use in radiofrequency (RF) heat lesion procedures for rel… | 1987 |
| * | — | Radionics TIC Cannula Named without a submission number |
What descends from it? (109)
See all 1096 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | 1998 | 108 |
| K021329 | Rita System | 2002 | 76 |
| K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman… | 2005 | 20 |
| K021942 | Radionics Pole Needles | 2002 | 15 |
| K042375 | SMK, CX, Cxe, RCN | 2004 | 12 |
| K040565 | Physician Industries Radiofrequency Ablation Needle | 2004 | 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?
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 RSM-C is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the same intended use as the SMK Cannula and TIC Cannula.
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/K963577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963577: Radionics Sluijter-Mehta Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963577
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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