510(k) · Cleared

Recalled · 2006

Cool-Tip RF System

K984552510(k) TraditionalCleared Mar 5, 199973-day reviewClass II21 CFR 878.4400Recalls 1

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

Radionics, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 5, 1999 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1,174 later devices descend from it. It has been recalled once.

Decided: Mar 5, 1999
Review: 73 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 0

1,174 later devices descend from it, 12 citing it directly.

This deviceK984552 Cool-Tip RF SystemRadionics, Inc. · 1999
Descendant · cites it directly · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
Descendant · 2 generations on · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
Descendant · 2 generations on · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
Descendant · 2 generations on · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
Descendant · 3 generations on · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003

Showing 5 of 1,174 descendants. See all descendants

Descendants cleared per year

2000high 132 (2025) · low 1 (2000)2026

Most influential descendants

Showing 5 of 1,174 · See all

K000944Thermage Thermacool SystemThermage, Inc. · 2000 · cites it directly1,069descendants
K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · 2 generations on800descendants
K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · 2 generations on799descendants
K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · 2 generations on789descendants
K030142Thermacool TC SystemThermage, Inc. · 2003 · 3 generations on773descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K984552	Cool-Tip RF System	Radionics, Inc.	1999	—
+1	K000944	Thermage Thermacool System	Thermage, Inc.	2000	—
+2	K013034	Modification to: Thermacool Iia	Thermage, Inc.	2001	—
+2	K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	—
+2	K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	—
+3	K030142	Thermacool TC System	Thermage, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2002	4	0
2003	12	0
2004	7	0
2005	15	0
2006	12	0
2007	18	0
2008	36	0
2009	28	0
2010	28	0
2011	20	0
2012	25	0
2013	37	0
2014	38	0
2015	49	0
2016	60	0
2017	64	0
2018	53	0
2019	46	0
2020	62	0
2021	63	0
2022	84	0
2023	82	0
2024	114	0
2025	132	0
2026	83	0

FIG. 1 — Lineage of K984552, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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?

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

What descends from it? (1,174)

See all 1,174

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

Number	Device	Applicant	Decided	Descendants
K000944	Thermage Thermacool System	Thermage, Inc.	2000	1,069
K072261	Finesse System	Primaeva Medical, Inc.	2007	100
K042216	Cool-Tip RF Ablation System	Valleylab	2004	75
K052796	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Valleylab	2006	56
K070101	Uniblate Electrosurgical Device	Rita Medical Systems, Inc.	2007	22
K052919	Microsulis Tissue Ablation System	Microsulis Americas, Inc.	2006	15
K072870	Microwave Tissue Coagulation System (MTCS)	Foundry Newco X, Inc.	2008	11
K070356	Medwaves Microwave Coagulation/Ablation System	Medwaves Incorporated	2007	2
K070446	Cool-Tip Switching Controller, CTSW Control	Valleylab,A Division of Tyco Healthcare Group LP	2007	2
K062935	Habib 4X Laparoscopic	Rita Medical Systems	2006	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 21, 2006	Not classified	Z-0859-06	Other	Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K000944 (Thermage, Inc., 2000) has gone furthest, with 1,069 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	—

What is it indicated for?

The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

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

https://510kreport.com/device/K984552 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984552: Cool-Tip RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984552

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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