510(k) Report

510(k) · Cleared

Cleared

Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter

K060183510(k) SpecialCleared Feb 16, 200623-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 Feb 16, 2006 as substantially equivalent to K013348 (Erbe USA, Inc., 2001) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 1989. 16 later devices descend from it.

Decided
Feb 16, 2006
Review
23 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K894762 (1989). 5 ancestors in all. 16 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1990: 1 other ancestor2024: 1 descendant cleared2025: 4 descendants cleared2018: 1 descendant cleared2015: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant cleared2020: 3 descendants cleared2022: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant clearedK894762 · 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. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant K013348 · 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. · 19890
  1. Root · 3 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 2 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. 1 generation backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. This deviceK060183 Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe…Erbe USA, Inc. · 2006
  5. Descendant · cites it directly · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
  6. Descendant · 2 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
  7. Descendant · cites it directly · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025
  8. Descendant · cites it directly · 1 of its ownK242044 FiAPC plus probesErbe Elektromedizin GmbH · 2024
  9. Descendant · 2 generations on · 1 of its ownK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2015: 12017: 12018: 12019: 12020: 32021: 12022: 12023: 22024: 12025: 4
2015high 4 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 16 · See all
  • K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · cites it directly12descendants
  • K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 2 generations on7descendants
  • K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · cites it directly1descendant
  • K242044FiAPC plus probesErbe Elektromedizin GmbH · 2024 · cites it directly1descendant
  • K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−2K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
−1K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158…Erbe USA, Inc.2001—
0 (this device)K060183Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterErbe USA, Inc.2006—
+1K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.2015—
+2K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.20172
+1K243120HybridAPC probeErbe Elektromedizin GmbH2025—
+1K242044FiAPC plus probesErbe Elektromedizin GmbH2024—
+2K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
201810
201910
202030
202110
202210
202320
202410
202540
FIG. 1 — Lineage of K060183, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…
Summary page 1
…ries (21 CFR878.4400) Product Code: GEl Legally Marketed Device: APC Connector Hose and Probes submitted in the ERBE 510(k) Number K013348 as well as APC Membrane Filter (as an Accessory) in ERBE 510(k) Number K024047 Note: The APC Integrated…
Erbe USA, Inc.2001—
*K024047Erbe Vio Apc with Accessories
Summary page 1
…obes submitted in the ERBE 510(k) Number K013348 as well as APC Membrane Filter (as an Accessory) in ERBE 510(k) Number K024047 Note: The APC Integrated Filter Probes and Adapter are being submitted in this premarket notification are modified from the acce…
Erbe USA, Inc.2003—

Also cleared against K013348: 6 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.201512
K243120HybridAPC probeErbe Elektromedizin GmbH20251
K242044FiAPC plus probesErbe Elektromedizin GmbH20241
K243451FiAPC plus probesErbe Elektromedizin GmbH20250
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 17 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K143306 (Erbe USA, Inc., 2015) has gone furthest, with 12 descendants of its own.
  • 6 other devices also cite its predicate K013348.

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

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?

Argon Plasma Coagulation (APC)

Indications for use as stated in the FDA summary.

Also cleared against K013348

6 other devices cite the same predicate.

  • K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012
  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 2011
  • K081644Beamer Argon ProbeConmed Corporation · 2008
  • K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
  • K081580Beamer Argon Snare ProbeConmed Corporation · 2008
  • K052035Canady Plasma ProbesCanady Technology, LLC · 2005

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

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The GEI category page

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https://510kreport.com/device/K060183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060183: Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060183

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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