510(k) · Cleared

Cleared

Zomed Model 30-6 Multielectrode Array Probe

K962692510(k) TraditionalCleared Sep 19, 199670-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

Zomed Intl. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 19, 1996 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 68 later devices descend from it.

Decided: Sep 19, 1996
Review: 70 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

68 later devices descend from it, 1 citing it directly.

This deviceK962692 Zomed Model 30-6 Multielectrode Array ProbeZomed Intl. · 1996
Descendant · cites it directly · 67 of its ownK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
Descendant · 2 generations on · 50 of its ownK053535 Vivawave Microwave Ablation SystemValleylab · 2006
Descendant · 2 generations on · 41 of its ownK070023 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007
Descendant · 3 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
Descendant · 4 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2002high 8 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 68 · See all

K011676Vivawave Microwave SystemVivant Medical, Inc. · 2002 · cites it directly67descendants
K053535Vivawave Microwave Ablation SystemValleylab · 2006 · 2 generations on50descendants
K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007 · 2 generations on41descendants
K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · 3 generations on39descendants
K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 4 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962692	Zomed Model 30-6 Multielectrode Array Probe	Zomed Intl.	1996	—
+1	K011676	Vivawave Microwave System	Vivant Medical, Inc.	2002	1
+2	K053535	Vivawave Microwave Ablation System	Valleylab	2006	—
+2	K070023	Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100	Microsurgeon, Inc.	2007	—
+3	K100744	Certus 140 Microwave Ablation System and Accessories, Model Certus 140	Neuwave Medical, Inc.	2010	—
+4	K113237	Certus 140 2.45GHZ Ablation System	Neuwave Medical, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2004	1	0
2006	2	0
2007	2	0
2008	2	0
2009	4	0
2010	2	0
2011	1	0
2012	2	0
2013	2	0
2014	1	0
2015	5	0
2016	4	0
2017	2	0
2018	3	0
2019	2	0
2020	6	0
2021	3	0
2022	1	0
2023	7	0
2024	8	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K962692, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K011676	Vivawave Microwave System	Vivant Medical, Inc.	2002	67

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?

Of its descendants, K011676 (Vivant Medical, Inc., 2002) has gone furthest, with 67 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	—

https://510kreport.com/device/K962692 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962692: Zomed Model 30-6 Multielectrode Array Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962692

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026