510(k) Report

510(k) · Cleared

Cleared

Erbe Model Vio 300 D with Accessories

K083452510(k) SpecialCleared Dec 31, 200840-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

Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 31, 2008 as substantially equivalent to K023886 (Erbe USA, Inc., 2002) and 1 other predicate after a 40-day review. Its family tree reaches back 3 generations to 1994. 55 later devices descend from it.

Decided
Dec 31, 2008
Review
40 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K933002 (1994). 55 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2019: 7 descendants cleared2020: 5 descendants cleared2017: 5 descendants cleared2022: 10 descendants cleared2018: 1 descendant cleared2016: 3 descendants cleared2014: 2 descendants cleared2025: 2 descendants cleared2024: 7 descendants cleared2026: 3 descendants cleared2021: 2 descendants cleared2023: 7 descendants clearedK933002 · Erbotom Icc 350 · Erbe USA, Inc. · 1994K023886 · Erbe Vio Esu with Accessories, Model Vio 300 D · Erbe USA, Inc. · 2002K060484 · Erbe Vio Esu, Model Vio 300 D · Erbe USA, Inc. · 20061990200020102020
Descendants, by generation 1 generation forward: 10 descendants2 generations forward: 8 descendants3 generations forward: 10 descendants4 generations forward: 9 descendants5 generations forward: 11 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants K060484 · Erbe Vio Esu, Model Vio 300 D · Erbe USA, Inc. · 2006K023886 · Erbe Vio Esu with Accessories, Model Vio 300 D · Erbe USA, Inc. · 2002K933002 · Erbotom Icc 350 · Erbe USA, Inc. · 19940+5
  1. Root · 3 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
  2. 2 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
  3. 1 generation backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
  4. This deviceK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
  5. Descendant · cites it directly · 39 of its ownK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
  6. Descendant · 2 generations on · 14 of its ownK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
  7. Descendant · 3 generations on · 12 of its ownK192813 Plasma IQNeauvia North America, Inc. · 2020
  8. Descendant · 2 generations on · 12 of its ownK142975 Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014
  9. Descendant · 3 generations on · 11 of its ownK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22016: 32017: 52018: 12019: 72020: 52021: 22022: 102023: 72024: 72025: 22026: 3
2013high 10 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 55 · See all
  • K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation · 2014 · cites it directly39descendants
  • K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation · 2016 · 2 generations on14descendants
  • K192813Plasma IQNeauvia North America, Inc. · 2020 · 3 generations on12descendants
  • K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014 · 2 generations on12descendants
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation · 2017 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K933002Erbotom Icc 350Erbe USA, Inc.1994—
−2K023886Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc.2002—
−1K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc.2006—
0 (this device)K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc.2008—
+1K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High…Bovie Medical Corporation2014—
+2K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical…Bovie Medical Corporation2016—
+3K192813Plasma IQNeauvia North America, Inc.2020—
+2K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation2014—
+3K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation20176

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201630
201750
201810
201970
202050
202120
2022100
202370
202470
202520
202630
FIG. 1 — Lineage of K083452, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K023886Erbe Vio Esu with Accessories, Model Vio 300 D
Summary page 1
…GEl Legially Marketed Predicate Device: ERIBE VIG ESU (Model VIO 300 D) with Accessories 510(k) Numbers: K023886 and K060484 Device Description: The ERBE ESU Model VIG 300 D with Accessories is an electrosurgical system that uses High Frequ…
Erbe USA, Inc.2002—
*K060484Erbe Vio Esu, Model Vio 300 D
Summary page 1
…GEl Legially Marketed Predicate Device: ERIBE VIG ESU (Model VIO 300 D) with Accessories 510(k) Numbers: K023886 and K060484 Device Description: The ERBE ESU Model VIG 300 D with Accessories is an electrosurgical system that uses High Frequency (HF) el…
Erbe USA, Inc.2006—

Also cleared against K023886: 8 other devices →

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation201439
K133180Erbe Esu Model Vio DV with AccessoriesErbe USA, Inc.20136
K150364ERBE ESU Model VIO dV with AccessoriesErbe Elektromedizin GmbH20165
K190823Erbe ESU Model VIO 3 with AccessoriesErbe Elektromedizin GmbH20192
K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.20171
K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250
K214058Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart…Conmed Corporation20220
K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200
K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd.20200
K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesOlympus Winter & Ibe GmbH20180

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 14 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K134054 (Bovie Medical Corporation, 2014) has gone furthest, with 39 descendants of its own.
  • 8 other devices also cite its predicate K023886.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
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

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Indications for use as stated in the FDA summary.

Also cleared against K023886

8 other devices cite the same predicate.

  • K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set…Corinth Medtech, Inc. · 2018
  • K162979Veloxion SystemCorinth Medtech, Inc. · 2017
  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 2011
  • K103032Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal Model WB50403W…Olympus Winter & Ibe GmbH · 2011
  • K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
  • K073207Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 20081 recall

More from Erbe USA, Inc.

39 FDA decisions under this applicant name. See the company

  • K221177Erbe's Tubing/Cap SetsErbe USA, Inc. · 20221 recall
  • K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
  • K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 20191 recall
  • K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
  • K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 20161 recall

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K083452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083452: Erbe Model Vio 300 D with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083452

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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