510(k) · Cleared

Cleared

joimax Electrosurgical Instruments

K161378510(k) TraditionalCleared Nov 2, 2016168-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

Joimax GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 2, 2016 as substantially equivalent to K014201 (Aaron Medical Industries, 2002) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.

Decided: Nov 2, 2016
Review: 168 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K931338 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK931338 16 Electrodes (Blade, Ball, Needle & Loop)Aaron Medical Industries · 1994
1 generation backK014201 Aaron Reusable Electrosurgical ElectrodeAaron Medical Industries · 2002
This deviceK161378 joimax Electrosurgical InstrumentsJoimax GmbH · 2016
Descendant · cites it directly · 0 of its ownK211173 maxmorespine Bipolar ElectrodesHoogland Spine Products, GmbH · 2022

Most influential descendants

Showing 1 of 1 · See all

K211173maxmorespine Bipolar ElectrodesHoogland Spine Products, GmbH · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K931338	16 Electrodes (Blade, Ball, Needle & Loop)	Aaron Medical Industries	1994	—
−1	K014201	Aaron Reusable Electrosurgical Electrode	Aaron Medical Industries	2002	—
0 (this device)	K161378	joimax Electrosurgical Instruments	Joimax GmbH	2016	—
+1	K211173	maxmorespine Bipolar Electrodes	Hoogland Spine Products, GmbH	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K161378, 1994–2022Source: 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
*	K014201	Aaron Reusable Electrosurgical Electrode Summary page 5 …Product Code: GEI III. PREDICATE DEVICE Primary Monopolar Predicate: Aaron Reusable Electrosurgical Electrode (K014201) Primary Bipolar Predicate: Bi Polar TRIGGER-Flex Electrode (K003126) IV. DEVICE…	Aaron Medical Industries	2002	—
*	K003126	Bipolar Trigger-Flex Probe Summary page 5 …dicate: Aaron Reusable Electrosurgical Electrode (K014201) Primary Bipolar Predicate: Bi Polar TRIGGER-Flex Electrode (K003126) IV. DEVICE DESCRIPTION The joimax® Electrosurgical Instruments are comprised of a series of…	Ellman Intl., Inc.	2001	—
†	K023986	Arthrex Opes Electrodes and Accessories	Arthrex, Inc.	2002	—
†	K130110	Meddusa Bipolar System	Elliquence, LLC	2013	—

Also cleared against K014201: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K211173	maxmorespine Bipolar Electrodes	Hoogland Spine Products, GmbH	2022	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 22 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K211173 (Hoogland Spine Products, GmbH, 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K014201.

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. 2016, 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?

joimax® Bipolar Electrosurgical Instruments The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used…

Read the full statement (129 words)

joimax® Bipolar Electrosurgical Instruments

The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.

The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

joimax® Monopolar Electrosurgical Instruments

The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.

The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161378 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161378: joimax Electrosurgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161378

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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