510(k) · Cleared

Cleared

Rita System

K021329510(k) TraditionalCleared Oct 9, 2002166-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

Rita Medical Systems · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 9, 2002 as substantially equivalent to K983214 (Rita Medical Systems, 2000) and 7 other predicates after a 166-day review. Its family tree reaches back 3 generations to 1987. 76 later devices descend from it.

Decided: Oct 9, 2002
Review: 166 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 8

Its longest line of descent runs back 3 generations to K870028 (1987). 9 ancestors in all. 76 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
2 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
1 generation backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
This deviceK021329 Rita SystemRita Medical Systems · 2002
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 · 3 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2004high 14 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 76 · 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 · 3 generations on39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K870028	SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible	Radionics, Inc.	1987	—
−2	K963577	Radionics Sluijter-Mehta Cannula	Radionics, Inc.	1996	—
−1	K980430	Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)	Radionics, Inc.	1998	—
0 (this device)	K021329	Rita System	Rita Medical Systems	2002	—
+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	—
+3	K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	2010	—

Other ancestors by year cleared

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

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	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 K021329, 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

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What was it cleared against? (8)

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
*	K983214	Rita RF Generator and Accessories, Model 500 Series Summary page 1 …cation Name: Electrosurgical Radiofrequency Generator and Electrosurrrical Devices Name of N T A Medical Systems Inc. - RITA@ System (K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequ…	Rita Medical Systems	2000	—
*	K992693	Rita Model 90 Electrosurgical Accessory, Model 90 Summary page 1 …me: Electrosurgical Radiofrequency Generator and Electrosurrrical Devices Name of N T A Medical Systems Inc. - RITA@ System (K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency syst…	Rita Medical Systems	1999	3
*	K993944	Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive… Summary page 1 …rosurgical Radiofrequency Generator and Electrosurrrical Devices Name of N T A Medical Systems Inc. - RITA@ System (K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency system (K9635…	Rita Medical Systems	1999	—
*	K003676	Rita Model 2500 Electrosurgical RF Generator Summary page 1 …ator and Electrosurrrical Devices Name of N T A Medical Systems Inc. - RITA@ System (K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency system (K963577,K965 182, K980430,K982489) C…	Rita Medical Systems	2001	—
*	K963577	Radionics Sluijter-Mehta Cannula Summary page 1 …nc. - RITA@ System (K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency system (K963577,K965 182, K980430,K982489) Classification Class II Performance The FDA under section 514 of the Food, Drug and C…	Radionics, Inc.	1996	—
*	K965182	RFG-3CF Summary page 1 …TA@ System (K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency system (K963577,K965 182, K980430,K982489) Classification Class II Performance The FDA under section 514 of the Food, Drug and Cosmetic A…	Radionics, Inc.	1997	—
*	K980430	Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) Summary page 1 …(K983214, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency system (K963577,K965 182, K980430,K982489) Classification Class II Performance The FDA under section 514 of the Food, Drug and Cosmetic Act has no…	Radionics, Inc.	1998	—
*	K982489	RFG-3C Plus Summary page 1 …4, K992693, K993944, Marketed Device K003676) - - Radionics Radiofiequency system (K963577,K965 182, K980430,K982489) Classification Class II Performance The FDA under section 514 of the Food, Drug and Cosmetic Act has not Standa…	Radionics, Inc.	1998	—

Also cleared against K983214: 1 other device →

What descends from it? (76)

See all 76

2 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
K120116	Serf Ablation System Serf Ablation Needle	Thermedical	2012	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 15 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K042216 (Valleylab, 2004) has gone furthest, with 75 descendants of its own.
1 other device also cites its predicate K983214.

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 RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including:

the partial or complete ablation of non-resectable liver lesions and

the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021329 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021329: Rita System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021329

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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