510(k) Report

510(k) · Cleared

Cleared

GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)

K251247510(k) TraditionalCleared Aug 7, 2025106-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

Boston Scientific Neuromodulation Corporation · GXD Generator, Lesion, Radiofrequency

Cleared on Aug 7, 2025 as substantially equivalent to K082051 (Cosman Medical, Inc., 2008) after a 106-day review. Its family tree reaches back 5 generations to 1987.

Decided
Aug 7, 2025
Review
106 days
Class
Class II
Product code
GXD
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K870028 (1987). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestorK870028 · 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 · recalledK082051 · Cosman G4 Radiofrequency Generator, Model RFG-4 · Cosman Medical, Inc. · 20081990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 4 other ancestors K082051 · Cosman G4 Radiofrequency Generator, Model RFG-4 · Cosman Medical, Inc. · 2008K050084 · 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. · 1987−50
  1. Root · 5 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
  2. 4 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
  3. 3 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
  4. 2 generations backK050084 Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal…Cosman Medical, Inc. · 2005 · Recalled
  5. 1 generation backK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  6. This deviceK251247 GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency…Boston Scientific Neuromodulation Corporation · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc.1987—
−4K963577Radionics Sluijter-Mehta CannulaRadionics, Inc.1996—
−3K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc.1998—
−2K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit…Cosman Medical, Inc.20053
−1K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.2008—
0 (this device)K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator…Boston Scientific Neuromodulation Corporation2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
200210
200610
FIG. 1 — Lineage of K251247, 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 K231675 OneRF Ablation Systemscore 10.7 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K082051Cosman G4 Radiofrequency Generator, Model RFG-4
Summary page 5
…Boston Scientific Neuromodulation Corporation Predicate Device Common Name: Radiofrequency Ablation Generator Predicate Device Premarket Notification # K082051 Predicate Device Regulation & Name Radiofrequency Lesion Generator (21 CFR 882.4400 Predicate Device Classification &…
Cosman Medical, Inc.2008—

Also cleared against K082051: 2 other devices →

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 38 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K082051.

How does its category compare?

All GXD devices

GXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Boston Scientific RFG-X1 (GX1) 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 Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes

Indications for use as stated in the FDA summary.

Also cleared against K082051

2 other devices cite the same predicate.

  • K231675OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
  • K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 20114 recalls

Recent decisions in GXD

The GXD category page

  • 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
  • K203293Abbott Medical Grounding Pad, model RF-DGP-ISAbbott Medical · 2022

https://510kreport.com/device/K251247 · printed Nov 5, 2026

Cite this page

510(k) Report. “K251247: GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251247

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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