510(k) · Cleared
Recalled · Class II · 2023NT 2000 Lesioning Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Therm, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Sep 20, 2011 as substantially equivalent to K052878 (Neuro Therm, Inc., 2006) and 2 other predicates after a 106-day review. Its family tree reaches back 5 generations to 1987. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 20, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- GXD
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 5 generations to K870028 (1987). 12 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 4 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 3 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 2 generations backK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
- 1 generation backK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
- This deviceK111576 NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK232632 Racz Neurostat RF GeneratorEpimed International · 2024
- Descendant · cites it directly · 0 of its ownK220122 APEX 6Rf Innovations, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK201610 IonicRF GeneratorAbbott Medical · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −4 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −3 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −2 | K050084 | Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit… | Cosman Medical, Inc. | 2005 | 3 |
| −1 | K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4 | Cosman Medical, Inc. | 2008 | — |
| 0 (this device) | K111576 | NT 2000 Lesioning Generator | Neuro Therm, Inc. | 2011 | — |
| +1 | K232632 | Racz Neurostat RF Generator | Epimed International | 2024 | — |
| +1 | K220122 | APEX 6 | Rf Innovations, Inc. | 2023 | — |
| +1 | K201610 | IonicRF Generator | Abbott Medical | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K052878 | NT-1000Summary page 1…21 CFR 882.4400 Radiofrequency lesion generator, Class 11 PRODUCT CODE: GXD C) PREDICATES: * NeuroTherm NT 1000 RF Lesioning Generator (K052878) * Stryker Multi-Gen Lesioning Generator (K07 1482) * Cosman G4 Radiofrequency Generator (K082051I) D) DEVICE… | 2006 |
| * | K071482 | Stryker RF Multi-Lesion Generator, Model 0406-900-000Summary page 1…s 11 PRODUCT CODE: GXD C) PREDICATES: * NeuroTherm NT 1000 RF Lesioning Generator (K052878) * Stryker Multi-Gen Lesioning Generator (K07 1482) * Cosman G4 Radiofrequency Generator (K082051I) D) DEVICE DESCRIPTION: The NeuroTherm NT 2000 is a desktop RF l… | 2007 |
| * | K082051 | Cosman G4 Radiofrequency Generator, Model RFG-4Summary page 1…ATES: * NeuroTherm NT 1000 RF Lesioning Generator (K052878) * Stryker Multi-Gen Lesioning Generator (K07 1482) * Cosman G4 Radiofrequency Generator (K082051I) D) DEVICE DESCRIPTION: The NeuroTherm NT 2000 is a desktop RF lesioning generator, which is used for the lesioning… | 2008 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Sep 28, 2023 | Class II | Z-0209-2024 | Process change control | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure. |
| Apr 22, 2021 | Class II | Z-1549-2021 | Process change control | Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission. |
| Oct 14, 2019 | Class II | Z-0664-2020 | Process control | Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin… |
| Oct 9, 2013 | Class II | Z-1361-2016 | Software Manufacturing/Software Deployment | NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K232632 (Epimed International, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K052878.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The NT 2000 is intended for use for lesioning of neural tissue. The NT 2000 is indicated for use in the peripheral nervous system.
The NT 2000 is to be used only with FDA cleared NeuroTherm RE probes and Smith & Nephew SPINECATH and ACUTHERM catheters.
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/K111576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111576: NT 2000 Lesioning Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111576
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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