510(k) · Cleared

Cleared

Cool-Tip RF Ablation System

K042216510(k) TraditionalCleared Nov 12, 200488-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

Valleylab · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 12, 2004 as substantially equivalent to K984552 (Radionics, Inc., 1999) and 6 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1987. 75 later devices descend from it.

Decided: Nov 12, 2004
Review: 88 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K870028 (1987). 15 ancestors in all. 75 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 4 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
3 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
2 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
1 generation backK021329 Rita SystemRita Medical Systems · 2002
This deviceK042216 Cool-Tip RF Ablation SystemValleylab · 2004
Descendant · cites it directly · 56 of its ownK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
Descendant · cites it directly · 50 of its ownK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
Descendant · 2 generations on · 42 of its ownK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
Descendant · 2 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
Descendant · 3 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2006high 14 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 75 · See all

K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · cites it directly56descendants
K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006 · cites it directly50descendants
K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008 · 2 generations on42descendants
K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · 2 generations on39descendants
K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 3 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K870028	SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible	Radionics, Inc.	1987	—
−3	K963577	Radionics Sluijter-Mehta Cannula	Radionics, Inc.	1996	—
−2	K980430	Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)	Radionics, Inc.	1998	—
−1	K021329	Rita System	Rita Medical Systems	2002	—
0 (this device)	K042216	Cool-Tip RF Ablation System	Valleylab	2004	—
+1	K052796	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	—
+1	K053290	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	—
+2	K072687	Valleylab Microwave Ablation Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2008	—
+2	K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	2010	—
+3	K113237	Certus 140 2.45GHZ Ablation System	Neuwave Medical, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	3	0
2000	2	0
2001	2	0
2003	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2012	3	0
2013	1	0
2014	1	0
2015	3	0
2016	3	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 K042216, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

Get a 510(k) Report

What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K984552	Cool-Tip RF System Summary page 1 …ipTM RF Ablation System is substantially equivalent to the following legally marketed medical devices: , Cool-tip Tm RF Ablation System (K984552) v RITA Medical Systems RF Generator and Accessories (K993944, K021329, K031257 and…	Radionics, Inc.	1999	1
*	K993944	Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive… Summary page 1 …ly marketed medical devices: , Cool-tip Tm RF Ablation System (K984552) v RITA Medical Systems RF Generator and Accessories (K993944, K021329, K031257 and K031926) V RadioTherapeutics RF Generator and LeVeen Electrod…	Rita Medical Systems	1999	—
*	K021329	Rita System Summary page 1 …, Cool-tip Tm RF Ablation System (K984552) v RITA Medical Systems RF Generator and Accessories (K993944, K021329, K031257 and K031926) V RadioTherapeutics RF Generator and LeVeen Electrode (K012315…	Rita Medical Systems	2002	—
*	K031257	Rita Model 1500X Electrosurgical RF Generator Summary page 1 …, Cool-tip Tm RF Ablation System (K984552) v RITA Medical Systems RF Generator and Accessories (K993944, K021329, K031257 and K031926) V RadioTherapeutics RF Generator and LeVeen Electrode (K012315 and K00…	Rita Medical Systems, Inc.	2003	—
*	K031926	Rita Model 1500X Electrosurgical RF Generator and Accessories (E.G., Rita Thermo Pad and… Summary page 1 …Cool-tip Tm RF Ablation System (K984552) v RITA Medical Systems RF Generator and Accessories (K993944, K021329, K031257 and K031926) V RadioTherapeutics RF Generator and LeVeen Electrode (K012315 and K000241) 4.…	Rita Medical Systems, Inc.	2003	1
*	K012315	Leveen Electrode Summary page 1 …RF Generator and Accessories (K993944, K021329, K031257 and K031926) V RadioTherapeutics RF Generator and LeVeen Electrode (K012315 and K000241) 4. Device Description The Cool-tipTM RF Ablation System consists of a mic…	Radiotherapeutics Corp.	2001	2
*	K000241	Radiotherapeutics RF 3000 Radiofrequency Generator Summary page 1 …4, K021329, K031257 and K031926) V RadioTherapeutics RF Generator and LeVeen Electrode (K012315 and K000241) 4. Device Description The Cool-tipTM RF Ablation System consists of a microprocessor based RF gener…	Radiotherapeutics Corp.	2000	—

Also cleared against K984552: 11 other devices →

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K052796	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	56
K053290	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	50
K163450	VIVA combo RF System	Starmed Co., Ltd.	2017	7
K083157	HS Amica	H.S Hospital Service S.P.A	2009	4
K070446	Cool-Tip Switching Controller, CTSW Control	Valleylab,A Division of Tyco Healthcare Group LP	2007	2
K223135	AblatePal Radiofrequency Ablation System	Compal Electronics, Inc.	2023	0

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 17 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
4 of the 15 ancestors have a recall of any class.
Of its descendants, K052796 (Valleylab, 2006) has gone furthest, with 56 descendants of its own.
11 other devices also cite its predicate K984552.

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	—

What is it indicated for?

The Cool-tipTM RF Ablation System (Generator and Accessories) is intended for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042216 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042216: Cool-Tip RF Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042216

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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