510(k) · Cleared
ClearedAPEX 6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rf Innovations, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Mar 15, 2023 as substantially equivalent to K111576 (Neuro Therm, Inc., 2011) after a 421-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Mar 15, 2023
- Review
- 421 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K870028 (1987). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 3 generations backK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
- 2 generations backK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
- 1 generation backK111576 NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · Recalled
- This deviceK220122 APEX 6Rf Innovations, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −5 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −4 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −3 | K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit… | Cosman Medical, Inc. | 2005 | 3 |
| −2 | K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4 | Cosman Medical, Inc. | 2008 | — |
| −1 | K111576 | NT 2000 Lesioning Generator | Neuro Therm, Inc. | 2011 | 4 |
| 0 (this device) | K220122 | APEX 6 | Rf Innovations, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | K111576 | NT 2000 Lesioning GeneratorSummary page 4…Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: II Product Code: GXD PREDICATE DEVICE: K111576 DEVICE NAME: NeuroTherm NT 2000 RF Lesioning Generator Regulation Number: 21 CFR 882.4400 Regulation Name:… | 2011 |
| † | K191293 | LCCS VC-S RF Cannula | 2020 |
| † | K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | 2016 |
| † | K140658 | Thermogard Dispersive Electrodes, Thermogard Plus Abc Dispersive Electrodes | 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 36 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 4 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111576.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220122: APEX 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220122
Report an extraction error
Are you the manufacturer?
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