510(k) · Cleared

Cleared

Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI

K094009510(k) TraditionalCleared Jun 14, 2010168-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

Halt Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 14, 2010 as substantially equivalent to K993944 (Rita Medical Systems, 1999) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1999. 10 later devices descend from it.

Decided: Jun 14, 2010
Review: 168 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K993944 (1999). 2 ancestors in all. 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK993944 Rita Model 1500 Electrosurgical Generator, Power…Rita Medical Systems · 1999
This deviceK094009 Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GIHalt Medical, Inc. · 2010
Descendant · cites it directly · 9 of its ownK121858 The Ablation SystemHalt Medical, Inc. · 2012
Descendant · 2 generations on · 6 of its ownK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
Descendant · 3 generations on · 5 of its ownK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
Descendant · 4 generations on · 4 of its ownK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
Descendant · 5 generations on · 3 of its ownK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012high 2 (2018) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all

K121858The Ablation SystemHalt Medical, Inc. · 2012 · cites it directly9descendants
K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018 · 2 generations on6descendants
K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020 · 3 generations on5descendants
K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021 · 4 generations on4descendants
K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993944	Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable…	Rita Medical Systems	1999	—
0 (this device)	K094009	Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI	Halt Medical, Inc.	2010	—
+1	K121858	The Ablation System	Halt Medical, Inc.	2012	—
+2	K173703	Sonata Sonography-Guided Transcervical Fibroid Ablation System	Gynesonics, Inc.	2018	—
+3	K193516	Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1	Gynesonics, Inc.	2020	—
+4	K211535	Sonata Transcervical Fibroid Ablation System 2.2	Gynesonics, Inc.	2021	—
+5	K222304	Sonata Transcervical Fibroid Ablation System 2.2	Gynesonics, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2018	2	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K094009, 1999–2025Source: 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? (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
*	K993944	Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive… Summary page 1 …tems - Electrosurgical RF which substantial equivalence is Generator and accessories: claimed * Rita Model 1500 (K993944) * Rita Model 150OX (K032 149) Intended Use The Halt 2 0 0 00 1 TM Electr…	Rita Medical Systems	1999	—
*	K032149	Rita Model 1500X Electrosurgical RF Generator Summary page 1 …Generator and accessories: claimed * Rita Model 1500 (K993944) * Rita Model 150OX (K032 149) Intended Use The Halt 2 0 0 00 1 TM Electrosurgical Radiofrequency Ablation System is indicated…	Rita Medical Systems, Inc.	2003	—

Also cleared against K993944: 5 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121858	The Ablation System	Halt Medical, Inc.	2012	9

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?

None of the 2 ancestors has a recall.
Of its descendants, K121858 (Halt Medical, Inc., 2012) has gone furthest, with 9 descendants of its own.
5 other devices also cite its predicate K993944.

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. 2010, 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 Halt 2000 G1™ Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K094009 · printed Nov 5, 2026

Cite this page

510(k) Report. “K094009: Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K094009

Report an extraction error

Are you the manufacturer?

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