510(k) Report

510(k) · Cleared

Cleared

Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator

K134054510(k) TraditionalCleared Mar 17, 201476-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

Bovie Medical Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 17, 2014 as substantially equivalent to K022856 (Aaron Medical Industries, 2003) and 1 other predicate after a 76-day review. Its family tree reaches back 4 generations to 1994. 39 later devices descend from it.

Decided
Mar 17, 2014
Review
76 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K933002 (1994). 7 ancestors in all. 39 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor2017: 4 descendants cleared2024: 5 descendants cleared2014: 1 descendant cleared2019: 5 descendants cleared2016: 2 descendants cleared2022: 8 descendants cleared2020: 3 descendants cleared2026: 2 descendants cleared2021: 2 descendants cleared2023: 6 descendants cleared2025: 1 descendant 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. · 2006K083452 · Erbe Model Vio 300 D with Accessories · Erbe USA, Inc. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 10 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants K083452 · Erbe Model Vio 300 D with Accessories · Erbe USA, Inc. · 2008K060484 · 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 · 4 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
  2. 3 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
  3. 2 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
  4. 1 generation backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
  5. This deviceK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
  6. Descendant · cites it directly · 14 of its ownK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
  7. Descendant · 2 generations on · 12 of its ownK192813 Plasma IQNeauvia North America, Inc. · 2020
  8. Descendant · cites it directly · 12 of its ownK142975 Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014
  9. Descendant · 2 generations on · 11 of its ownK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
  10. Descendant · cites it directly · 7 of its ownK170107 Surgi Max UltraElliquence, LLC · 2017

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22017: 42019: 52020: 32021: 22022: 82023: 62024: 52025: 12026: 2
2014high 8 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 39 · See all
  • K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation · 2016 · cites it directly14descendants
  • K192813Plasma IQNeauvia North America, Inc. · 2020 · 2 generations on12descendants
  • K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014 · cites it directly12descendants
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation · 2017 · 2 generations on11descendants
  • K170107Surgi Max UltraElliquence, LLC · 2017 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K933002Erbotom Icc 350Erbe USA, Inc.1994—
−3K023886Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc.2002—
−2K060484Erbe Vio Esu, Model Vio 300 DErbe USA, Inc.2006—
−1K083452Erbe Model Vio 300 D with AccessoriesErbe USA, Inc.2008—
0 (this device)K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High…Bovie Medical Corporation2014—
+1K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical…Bovie Medical Corporation2016—
+2K192813Plasma IQNeauvia North America, Inc.2020—
+1K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation2014—
+2K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation20176
+1K170107Surgi Max UltraElliquence, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201740
201950
202030
202120
202280
202360
202450
202510
202620
FIG. 1 — Lineage of K134054, 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
*K022856Bovie Ids-300 High Frequency Electrosurgical Generator
Summary page 1
…Accessories Classification: 2 1CFR 878.4400; Class 11; Product Code GEl Legally Marketed Predicate Device(s): 5 10(k) Number: K022856 Primary Predicate Device Name: Bovie IDS-300 High Fre…
Aaron Medical Industries2003—
*K083452Erbe Model Vio 300 D with Accessories
Summary page 1
…Electrosurgical Generator Manufacturer: Boyle Medical Corporation 5 10(k) Number: K083452 Secondary Predicate Name: ERBE VIO ESU (Model VIO 300…
Erbe USA, Inc.2008—

Also cleared against K022856: 4 other devices →

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation201614
K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412
K170107Surgi Max UltraElliquence, LLC20177
K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195
K162656ESU-1 Electrosurgical GeneratorTva Medical, Inc.20161
K240975Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)Beijing Taktvoll Technology Co., Ltd.20240

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 20 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K161134 (Bovie Medical Corporation, 2016) has gone furthest, with 14 descendants of its own.
  • 4 other devices also cite its predicate K022856.

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. 2014, 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 IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

Indications for use as stated in the FDA summary.

Also cleared against K022856

4 other devices cite the same predicate.

  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 2011
  • K082109Bovie Icon General Purpose RF GeneratorBovie Medical · 2008
  • K072041Bovie Ids-400 Electrosurgical GeneratorBovie Medical · 2008
  • K061884Bovie Icon GI Electrosurgical Generator, Model GI 120Bovie Medical · 2006

More from Bovie Medical Corporation

14 FDA decisions under this applicant name. See the company

  • K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise…Bovie Medical Corporation · 20191 recall
  • K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorBovie Medical Corporation · 20176 recalls
  • K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar…Bovie Medical Corporation · 20163 recalls
  • K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942…Bovie Medical Corporation · 2016

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K134054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K134054: Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134054

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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