510(k) Report

510(k) · Cleared

Cleared

Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm

K221945510(k) SpecialCleared Jul 28, 202223-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

Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 28, 2022 as substantially equivalent to K081644 (Conmed Corporation, 2008) after a 23-day review. Its family tree reaches back 5 generations to 1989.

Decided
Jul 28, 2022
Review
23 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K894762 (1989). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1990: 1 other ancestorK894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 1989K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K013348 · Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 · Erbe USA, Inc. · 2001K052035 · Canady Plasma Probes · Canady Technology, LLC · 2005K081644 · Beamer Argon Probe · Conmed Corporation · 20081990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor4 generations back: 1 other ancestor K081644 · Beamer Argon Probe · Conmed Corporation · 2008K052035 · Canady Plasma Probes · Canady Technology, LLC · 2005K013348 · Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 · Erbe USA, Inc. · 2001K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 1989−50
  1. Root · 5 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 4 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. 3 generations backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. 2 generations backK052035 Canady Plasma ProbesCanady Technology, LLC · 2005
  5. 1 generation backK081644 Beamer Argon ProbeConmed Corporation · 2008
  6. This deviceK221945 Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer…Conmed Corporation · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−4K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
−3K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158…Erbe USA, Inc.2001—
−2K052035Canady Plasma ProbesCanady Technology, LLC2005—
−1K081644Beamer Argon ProbeConmed Corporation2008—
0 (this device)K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER…Conmed Corporation2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199910
FIG. 1 — Lineage of K221945, 1989–2022Source: 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
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What was it cleared against? (1)

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
*K081644Beamer Argon Probe
Summary page 4
…Trade Name Manufacturer Number Code ConMed Beamer® Argon K081644 GEI ConMed Corporation Probe…
Conmed Corporation2008—

Also cleared against K081644: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 33 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
  • None of the 7 ancestors has a recall.
  • 1 other device also cites its predicate K081644.

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. 2022, 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 Beamer AVEOTM Filter Integrated Argon Probes and Beamer AVEOTM Filter Integrated Argon SideFire Probe are intended to be used for argon enhanced coagulation of tissue.

Indications for use as stated in the FDA summary.

Also cleared against K081644

1 other device cites the same predicate.

  • K130983Genii Arc Smart Argon ProbeGenii, Inc. · 2013

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84 FDA decisions under this applicant name. See the company

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The GEI category page

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https://510kreport.com/device/K221945 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221945: Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221945

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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