510(k) Report

510(k) · Cleared

Cleared

Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166

K013348510(k) SpecialCleared Oct 26, 200117-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 Oct 26, 2001 as substantially equivalent to K963189 (Erbe USA, Inc., 1996) after a 17-day review. Its family tree reaches back 2 generations to 1989. 30 later devices descend from it.

Decided
Oct 26, 2001
Review
17 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K894762 (1989). 3 ancestors in all. 30 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor2008: 3 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared2024: 2 descendants cleared2025: 5 descendants cleared2018: 1 descendant cleared2015: 1 descendant cleared2009: 1 descendant cleared2022: 2 descendants cleared2013: 1 descendant cleared2019: 2 descendants cleared2023: 2 descendants cleared2017: 1 descendant cleared2020: 3 descendants 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. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 11 descendants3 generations forward: 4 descendants4 generations forward: 7 descendants5 generations forward: 1 descendant K963189 · Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories · Erbe USA, Inc. · 1996K894762 · B100 Disposable Handpiece · Beacon Laboratories, Inc. · 19890+5
  1. Root · 2 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 1 generation backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. This deviceK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. Descendant · cites it directly · 16 of its ownK060183 Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe…Erbe USA, Inc. · 2006
  5. Descendant · 2 generations on · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
  6. Descendant · 3 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
  7. Descendant · cites it directly · 6 of its ownK052035 Canady Plasma ProbesCanady Technology, LLC · 2005
  8. Descendant · cites it directly · 2 of its ownK100669 Canady Plasma Electrosurgical Unit Series with Accessory Probes and…Us Medical Innovations, LLC · 2011

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 32009: 12011: 12012: 22013: 12015: 12017: 12018: 12019: 22020: 32021: 12022: 22023: 22024: 22025: 5
2005high 5 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all
  • K060183Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterErbe USA, Inc. · 2006 · cites it directly16descendants
  • K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · 2 generations on12descendants
  • K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 3 generations on7descendants
  • K052035Canady Plasma ProbesCanady Technology, LLC · 2005 · cites it directly6descendants
  • K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC · 2011 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−1K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
0 (this device)K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158…Erbe USA, Inc.2001—
+1K060183Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterErbe USA, Inc.2006—
+2K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.2015—
+3K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.20172
+1K052035Canady Plasma ProbesCanady Technology, LLC2005—
+1K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200830
200910
201110
201220
201310
201510
201710
201810
201920
202030
202110
202220
202320
202420
202550
FIG. 1 — Lineage of K013348, 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? (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
*K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…
Summary page 1
…Code: ' 79GEI Legally Marketed Device: Accessories (APC Connector Hose and Probes) submitted in the ERBE APC 300 Argon Plasma Coagulator and Accessories, 510(k) Number: K963189 Note: The APC Connector Hose and Probes being submitted in this premarket notification are modified from the accessories in the…
Erbe USA, Inc.1996—

Also cleared against K963189: 9 other devices →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K060183Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe AdapterErbe USA, Inc.200616
K052035Canady Plasma ProbesCanady Technology, LLC20056
K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112
K081644Beamer Argon ProbeConmed Corporation20082
K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc.20121
K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG20081
K081580Beamer Argon Snare ProbeConmed Corporation20081

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 12 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K060183 (Erbe USA, Inc., 2006) has gone furthest, with 16 descendants of its own.
  • 9 other devices also cite its predicate K963189.

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?

APC Coagulation

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963189

9 other devices cite the same predicate.

  • K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012
  • K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
  • K061909Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc. · 2006
  • K052035Canady Plasma ProbesCanady Technology, LLC · 2005
  • K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
  • K042274PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd. · 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

Recent decisions in GEI

The GEI category page

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https://510kreport.com/device/K013348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013348: Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013348

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026