510(k) · Cleared
ClearedRulo Radiofrequency Lesion Probe
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 Mar 8, 2019 as substantially equivalent to K141586 (Diros Technology, Inc., 2014) after a 29-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Mar 8, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K870028 (1987). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations between
- 3 generations backK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
- 2 generations backK102566 Owl CannulaeDiros Technology, Inc. · 2011
- 1 generation backK141586 Owl CannulaeDiros Technology, Inc. · 2014
- This deviceK190256 Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 9 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 8 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 7 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
- 6 generations backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
- 5 generations backK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- 4 generations backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- 3 generations backK080771 Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
- 2 generations backK102566 Owl CannulaeDiros Technology, Inc. · 2011
- 1 generation backK141586 Owl CannulaeDiros Technology, Inc. · 2014
- This deviceK190256 Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −9 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −8 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −7 | K021942 | Radionics Pole Needles | Radionics, A Division of Tyco Healthcare Group LP | 2002 | — |
| −6 | K042375 | SMK, CX, Cxe, RCN | Technomed Europe | 2004 | — |
| −5 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −4 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −3 | K080771 | Top Neuropole Needle, Model SH, BL, SC, TC | Top Corp. | 2008 | — |
| −2 | K102566 | Owl Cannulae | Diros Technology, Inc. | 2011 | — |
| −1 | K141586 | Owl Cannulae | Diros Technology, Inc. | 2014 | — |
| 0 (this device) | K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K141586 | Owl CannulaeSummary page 4…Predicate Device(s) Information: Predicate Device: Diros OWL Sterile Single Use R.F. Insulated Cannulae Models 466 and DHC (K141586) Device Description: The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency (RF) lesions o… | 2014 |
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 32 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K141586.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Rulo™ Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190256: Rulo Radiofrequency Lesion Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190256
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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