510(k) Report

510(k) · Cleared

Cleared

Cosman G4 Radiofrequency Generator, Model RFG-4

K082051510(k) TraditionalCleared Oct 16, 200890-day reviewClass II21 CFR 882.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cosman Medical, Inc. · GXD Generator, Lesion, Radiofrequency

Cleared on Oct 16, 2008 as substantially equivalent to K050084 (Cosman Medical, Inc., 2005) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1987. 7 later devices descend from it.

Decided
Oct 16, 2008
Review
90 days
Class
Class II
Product code
GXD
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K870028 (1987). 9 ancestors in all. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor2011: 1 descendant cleared2025: 2 descendants cleared2023: 2 descendants cleared2020: 1 descendant cleared2024: 1 descendant clearedK870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 1987K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K050084 · Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit; · Cosman Medical, Inc. · 2005 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants K050084 · Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit; · Cosman Medical, Inc. · 2005 · recalledK980430 · Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) · Radionics, Inc. · 1998K963577 · Radionics Sluijter-Mehta Cannula · Radionics, Inc. · 1996K870028 · SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible · Radionics, Inc. · 19870
  1. Root · 4 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 3 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 2 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. 1 generation backK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
  5. This deviceK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  6. Descendant · cites it directly · 3 of its ownK111576 NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · Recalled
  7. Descendant · cites it directly · 1 of its ownK231675 OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
  8. Descendant · 2 generations on · 0 of its ownK251243 OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025
  9. Descendant · cites it directly · 0 of its ownK251247 GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency…Boston Scientific Neuromodulation Corporation · 2025
  10. Descendant · 2 generations on · 0 of its ownK232632 Racz Neurostat RF GeneratorEpimed International · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12020: 12023: 22024: 12025: 2
2011high 2 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · cites it directly3descendants
  • K231675OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023 · cites it directly1descendant
  • K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025 · 2 generations on0descendants
  • K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…Boston Scientific Neuromodulation Corporation · 2025 · cites it directly0descendants
  • K232632Racz Neurostat RF GeneratorEpimed International · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−3K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−2K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
−1K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit…Cosman Medical, Inc.20053
0 (this device)K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.2008—
+1K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.20114
+1K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.2023—
+2K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.2025—
+1K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator…Boston Scientific Neuromodulation Corporation2025—
+2K232632Racz Neurostat RF GeneratorEpimed International2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202010
202320
202410
202520
FIG. 1 — Lineage of K082051, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…
Summary page 1
…ug, and Cosmetic Act. Predicate Devices: Cosman RF Lesion Generator, model RFG-1A (FDA Substantial Equivalence, K050084) NeuroTherm RF Pain Management Generator NT1000 (FDA…
Cosman Medical, Inc.20053
*K052878NT-1000
Summary page 1
…lence, K050084) NeuroTherm RF Pain Management Generator NT1000 (FDA Substantial Equivalence, K052878) Statement of Intended Use: The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency l…
Neuro Therm, Inc.2006—

Also cleared against K050084: 5 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.20113
K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.20231
K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…Boston Scientific Neuromodulation Corporation20250

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 21 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K111576 (Neuro Therm, Inc., 2011) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K050084.

How does its category compare?

All GXD devices

GXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GXD

1in 2025

2007: 42008: 22010: 12011: 22017: 22019: 12020: 22022: 12023: 22024: 22025: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXD

185in 2007

2007: 185 days median
2007high 185 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXD

1in 2023

2010: 12016: 12019: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXD

88in 2025

2007: 102008: 102009: 122010: 692011: 892012: 772013: 1192014: 642015: 672016: 512017: 832018: 1562019: 1952020: 1382021: 1542022: 842023: 542024: 632025: 88
2007high 195 (2019) · low 10 (2007)2025

MAUDE reports naming product code GXD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074185010
20082—010
20090—012
20101—169
20112—089
20120—077
20130—0119
20140—064
20150—067
20160—151
20172—083
20180—0156
20191—1195
20202—0138
20210—0154
20221—084
20232—154
20242—063
20251—088
20260—0—

What is it indicated for?

The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.

Indications for use as stated in the FDA summary.

Also cleared against K050084

5 other devices cite the same predicate.

  • K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp. · 2025
  • K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation · 20197 recalls
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006

More from Cosman Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K101131Fiducial MarkersCosman Medical, Inc. · 2010
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  • K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal…Cosman Medical, Inc. · 20053 recalls

Recent decisions in GXD

The GXD category page

  • K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1…Boston Scientific Neuromodulation Corporation · 2025
  • K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc. · 2024
  • K232632Racz Neurostat RF GeneratorEpimed International · 2024
  • K231675OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
  • K220122APEX 6Rf Innovations, Inc. · 2023

https://510kreport.com/device/K082051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082051: Cosman G4 Radiofrequency Generator, Model RFG-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082051

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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