510(k) · Cleared
Recalled · Class II · 2013BMC RF Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Jul 17, 1998 after a 350-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 17, 1998
- Review
- 350 days
- Class
- Class II
- Product code
- GXI
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK972846 BMC RF CannulaBaylis Medical Co., Inc. · 1998
- 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 · cites it directly · 2 of its ownK121773 Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeBiomerics · 2012
- Descendant · cites it directly · 1 of its ownK092337 Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS…Baylis Medical Co., Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK190259 Vesta RF CannulaBiomerics · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K102566Owl CannulaeDiros Technology, Inc. · 2011 · cites it directly3descendants
- K141586Owl CannulaeDiros Technology, Inc. · 2014 · 2 generations on2descendants
- K121773Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeBiomerics · 2012 · cites it directly2descendants
- K092337Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CSBaylis Medical Co., Inc. · 2009 · cites it directly1descendant
- K190259Vesta RF CannulaBiomerics · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972846 | BMC RF Cannula | Baylis Medical Co., Inc. | 1998 | — |
| +1 | K102566 | Owl Cannulae | Diros Technology, Inc. | 2011 | — |
| +2 | K141586 | Owl Cannulae | Diros Technology, Inc. | 2014 | — |
| +1 | K121773 | Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode | Biomerics | 2012 | — |
| +1 | K092337 | Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | Baylis Medical Co., Inc. | 2009 | — |
| +2 | K190259 | Vesta RF Cannula | Biomerics | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2013 | Class II | Z-0850-2014 | Employee error | Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label. |
| Oct 4, 2012 | Class II | Z-0879-2013 | Packaging | A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102566 (Diros Technology, Inc., 2011) has gone furthest, with 3 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?
The BMC RF Cannula 1s intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972846: BMC RF Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972846
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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