510(k) Report

510(k) · Cleared

Cleared

Radiotherapeutics RF-2000 Radiofrequency Generator

K981672510(k) TraditionalCleared Jul 17, 199866-day reviewClass II21 CFR 878.4400

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

Radiotherapeutics Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 17, 1998 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 113 later devices descend from it.

Decided
Jul 17, 1998
Review
66 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

113 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2002: 2 descendants cleared2001: 1 descendant cleared2008: 4 descendants cleared2006: 7 descendants cleared2007: 3 descendants cleared2003: 6 descendants cleared2016: 6 descendants cleared2004: 4 descendants cleared2005: 1 descendant cleared2010: 5 descendants cleared2009: 7 descendants cleared2015: 6 descendants cleared2018: 5 descendants cleared2012: 4 descendants cleared2014: 3 descendants cleared2019: 4 descendants cleared2013: 3 descendants cleared2011: 1 descendant cleared2023: 7 descendants cleared2024: 10 descendants cleared2017: 4 descendants cleared2025: 3 descendants cleared2021: 6 descendants cleared2020: 7 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK981672 Radiotherapeutics RF-2000 Radiofrequency GeneratorRadiotherapeutics Corp. · 1998
  2. Descendant · cites it directly · 67 of its ownK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 50 of its ownK053535 Vivawave Microwave Ablation SystemValleylab · 2006
  4. Descendant · cites it directly · 44 of its ownK994173 Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech…Stellartech Research Corp. · 2000
  5. Descendant · cites it directly · 42 of its ownK023765 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
  6. Descendant · cites it directly · 42 of its ownK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001

Showing 5 of 113 descendants. See all descendants

Descendants cleared per year

2000: 12001: 12002: 22003: 62004: 42005: 12006: 72007: 32008: 42009: 72010: 52011: 12012: 42013: 32014: 32015: 62016: 62017: 42018: 52019: 42020: 72021: 62022: 12023: 72024: 102025: 32026: 2
2000high 10 (2024) · low 1 (2000)2026

Most influential descendants

Showing 5 of 113 · See all
  • K011676Vivawave Microwave SystemVivant Medical, Inc. · 2002 · cites it directly67descendants
  • K053535Vivawave Microwave Ablation SystemValleylab · 2006 · 2 generations on50descendants
  • K994173Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech Radiofrequency…Stellartech Research Corp. · 2000 · cites it directly44descendants
  • K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002 · cites it directly42descendants
  • K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001 · cites it directly42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981672Radiotherapeutics RF-2000 Radiofrequency GeneratorRadiotherapeutics Corp.1998—
+1K011676Vivawave Microwave SystemVivant Medical, Inc.20021
+2K053535Vivawave Microwave Ablation SystemValleylab2006—
+1K994173Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech…Stellartech Research Corp.2000—
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2002—
+1K013139Stellartech Coagulation SystemStellartech Research Corp.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200220
200360
200440
200510
200670
200730
200840
200970
201050
201110
201240
201330
201430
201560
201660
201740
201850
201940
202070
202160
202210
202370
2024100
202530
202620
FIG. 1 — Lineage of K981672, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (113)

See all 113

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

NumberDeviceApplicantDecidedDescendants
K011676Vivawave Microwave SystemVivant Medical, Inc.200267
K994173Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech Radiofrequency…Stellartech Research Corp.200044
K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242
K013139Stellartech Coagulation SystemStellartech Research Corp.200142

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?

  • Of its descendants, K011676 (Vivant Medical, Inc., 2002) has gone furthest, with 67 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Radiotherapeutics Corp.

12 FDA decisions under this applicant name. See the company

  • K011220Leveen Reflect Monopolar/Bipolar Needle ElectrodeRadiotherapeutics Corp. · 2002
  • K012315Leveen ElectrodeRadiotherapeutics Corp. · 20012 recalls
  • K000241Radiotherapeutics RF 3000 Radiofrequency GeneratorRadiotherapeutics Corp. · 2000
  • K982556Leveen Needle ElectrodeRadiotherapeutics Corp. · 200011 recalls
  • K000032Leveen Needle ElectrodeRadiotherapeutics Corp. · 20003 recalls

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The GEI category page

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https://510kreport.com/device/K981672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981672: Radiotherapeutics RF-2000 Radiofrequency Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981672

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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