510(k) · Cleared
Recalled · Class II · 2020RF Introduction Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Sep 16, 2004 as substantially equivalent to K980430 (Radionics, Inc., 1998) after a 149-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 16, 2004
- Review
- 149 days
- Class
- Class II
- Product code
- GXI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K870028 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 2 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 1 generation backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- This deviceK041021 RF Introduction CannulaEpimed International, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK102566 Owl CannulaeDiros Technology, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK141586 Owl CannulaeDiros Technology, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK190256 Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK150371 Diros OWL Sterile Single Use TridentTM R.F. Insulated…Diros Technology, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K102566Owl CannulaeDiros Technology, Inc. · 2011 · cites it directly3descendants
- K141586Owl CannulaeDiros Technology, Inc. · 2014 · 2 generations on2descendants
- K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019 · 3 generations on0descendants
- K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −2 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −1 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| 0 (this device) | K041021 | RF Introduction Cannula | Epimed International, Inc. | 2004 | — |
| +1 | K102566 | Owl Cannulae | Diros Technology, Inc. | 2011 | — |
| +2 | K141586 | Owl Cannulae | Diros Technology, Inc. | 2014 | — |
| +3 | K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Summary page 1…Name: Disposable Cannula for Radiofrequency Electrode Product Class/Classification: Class II Predicate Device(s): Radionics Disposable RF Cannulae (K980430) Cotop International RF Cannula (K# unknown) Description: The Epimed RF Introduction Cannula consists of a coated st… | 1998 |
| * | — | Cotop International RF Cannula Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102566 | Owl Cannulae | 2011 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2020 | Class II | Z-1849-2020 | Labeling design | Incorrect expiration date on introduction cannula packaging. |
| Feb 21, 2020 | Class II | Z-1850-2020 | Labeling design | Incorrect expiration date on introduction cannula packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102566 (Diros Technology, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K980430.
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 Epimed RF Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041021: RF Introduction Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041021
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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