510(k) · Cleared

Cleared

Radiotherapeutics RF 3000 Radiofrequency Generator

K000241510(k) TraditionalCleared Apr 14, 200078-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 Apr 14, 2000 after a 78-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 79 later devices descend from it.

Decided: Apr 14, 2000
Review: 78 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

79 later devices descend from it, 3 citing it directly.

This deviceK000241 Radiotherapeutics RF 3000 Radiofrequency GeneratorRadiotherapeutics Corp. · 2000
Descendant · cites it directly · 75 of its ownK042216 Cool-Tip RF Ablation SystemValleylab · 2004
Descendant · 2 generations on · 56 of its ownK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
Descendant · 2 generations on · 50 of its ownK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
Descendant · 3 generations on · 42 of its ownK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
Descendant · cites it directly · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2004high 14 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 79 · See all

K042216Cool-Tip RF Ablation SystemValleylab · 2004 · cites it directly75descendants
K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 2 generations on56descendants
K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · 2 generations on50descendants
K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008 · 3 generations on42descendants
K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · cites it directly39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000241	Radiotherapeutics RF 3000 Radiofrequency Generator	Radiotherapeutics Corp.	2000	—
+1	K042216	Cool-Tip RF Ablation System	Valleylab	2004	—
+2	K052796	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	—
+2	K053290	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	—
+3	K072687	Valleylab Microwave Ablation Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2008	—
+1	K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2007	1	0
2008	2	0
2009	2	0
2010	1	0
2012	3	0
2013	1	0
2014	2	0
2015	3	0
2016	4	0
2017	4	0
2018	3	0
2019	5	0
2020	8	0
2021	3	0
2022	3	0
2023	9	0
2024	14	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K000241, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (79)

See all 79

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

Number	Device	Applicant	Decided	Descendants
K042216	Cool-Tip RF Ablation System	Valleylab	2004	75
K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	2010	39
K092487	Haloflex Energy Generator, Models 1190A-115A and 1190A-230A	Barrx Medical, Incorporated	2009	2

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, K042216 (Valleylab, 2004) has gone furthest, with 75 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

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

https://510kreport.com/device/K000241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000241: Radiotherapeutics RF 3000 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/K000241

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026