510(k) · Cleared

Cleared

Uniblate Electrosurgical Device

K070101510(k) TraditionalCleared Feb 14, 200735-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, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 14, 2007 as substantially equivalent to K010060 (Rita Medical Systems, 2001) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1999. 22 later devices descend from it.

Decided: Feb 14, 2007
Review: 35 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K984552 (1999). 2 ancestors in all. 22 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK984552 Cool-Tip RF SystemRadionics, Inc. · 1999 · Recalled
This deviceK070101 Uniblate Electrosurgical DeviceRita Medical Systems, Inc. · 2007
Descendant · cites it directly · 11 of its ownK080376 Oncobionic SystemOncobionic Incorporated · 2008 · Recalled
Descendant · 2 generations on · 10 of its ownK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
Descendant · 3 generations on · 8 of its ownK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
Descendant · cites it directly · 8 of its ownK080451 Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008
Descendant · 4 generations on · 7 of its ownK183385 NanoKnife SystemAngiodynamics · 2019 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008high 4 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all

K080376Oncobionic SystemOncobionic Incorporated · 2008 · cites it directly11descendants
K102329Nanoknife SystemAngioDynamics, Inc. · 2011 · 2 generations on10descendants
K150089NanoKnife SystemAngioDynamics, Inc. · 2015 · 3 generations on8descendants
K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008 · cites it directly8descendants
K183385NanoKnife SystemAngiodynamics · 2019 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K984552	Cool-Tip RF System	Radionics, Inc.	1999	1
0 (this device)	K070101	Uniblate Electrosurgical Device	Rita Medical Systems, Inc.	2007	—
+1	K080376	Oncobionic System	Oncobionic Incorporated	2008	1
+2	K102329	Nanoknife System	AngioDynamics, Inc.	2011	1
+3	K150089	NanoKnife System	AngioDynamics, Inc.	2015	1
+1	K080451	Uniblate Electrosurgical Device	AngioDynamics, Inc.	2008	—
+4	K183385	NanoKnife System	Angiodynamics	2019	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2011	1	0
2015	1	0
2017	1	0
2019	2	0
2020	1	0
2022	2	0
2023	2	0
2024	4	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K070101, 1999–2026Source: 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? (2)

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
*	K010060	Rita Starburst Xli Electrosurgical Device	Rita Medical Systems	2001	3
*	K984552	Cool-Tip RF System Summary page 1 …: Class II per 21 CFR 878.4400 Product Code: GEl Predicate Devices: StarBurst XLi (KOl 0060) Cool-Tip RF System (K984552) Intended Use: The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, la…	Radionics, Inc.	1999	1

Also cleared against K010060: 1 other device →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K080376	Oncobionic System	Oncobionic Incorporated	2008	11
K080451	Uniblate Electrosurgical Device	AngioDynamics, Inc.	2008	8
K080287	Oncobionic Bipolar Electrode	AngioDynamics, Inc.	2008	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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K080376 (Oncobionic Incorporated, 2008) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K010060.

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. 2007, this device’s year, is highlighted.

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 Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070101 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070101: Uniblate Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070101

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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