510(k) Report

510(k) · Cleared

Cleared

Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades

K100669510(k) TraditionalCleared Apr 6, 2011393-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

Us Medical Innovations, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 6, 2011 as substantially equivalent to K052035 (Canady Technology, LLC, 2005) and 6 other predicates after a 393-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it.

Decided
Apr 6, 2011
Review
393 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K894762 (1989). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2002: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor1990: 1 other ancestor2019: 1 descendant cleared2024: 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. · 2001K052035 · Canady Plasma Probes · Canady Technology, LLC · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K052035 · 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. · 19890
  1. Root · 4 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
  2. 3 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
  3. 2 generations backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
  4. 1 generation backK052035 Canady Plasma ProbesCanady Technology, LLC · 2005
  5. This deviceK100669 Canady Plasma Electrosurgical Unit Series with Accessory Probes and…Us Medical Innovations, LLC · 2011
  6. Descendant · cites it directly · 1 of its ownK192124 Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019
  7. Descendant · 2 generations on · 0 of its ownK240297 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024

Most influential descendants

Showing 2 of 2 · See all
  • K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019 · cites it directly1descendant
  • K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K894762B100 Disposable HandpieceBeacon Laboratories, Inc.1989—
−3K963189Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator…Erbe USA, Inc.1996—
−2K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158…Erbe USA, Inc.2001—
−1K052035Canady Plasma ProbesCanady Technology, LLC2005—
0 (this device)K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC2011—
+1K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC2019—
+2K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199420
199510
199910
200010
200210
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202410
FIG. 1 — Lineage of K100669, 1989–2024Source: 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? (7)

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
*K052035Canady Plasma Probes
Summary page 1
…ral, Restorative, and Neurological Devices Product Code: GEl Class: H Predicate Device Information: Canady Technology, LLC Canady Plasma Probes for Flexible Endoscopy - K05203 5 ERBE ICC 200 -K933157 ERBE VIO 300D - K023886 ERLBE VIG APC2 - K024047 ERBE APC Applications - KO 13348 Valley Lab Force FX - K94…
Canady Technology, LLC2005—
*K933157Erbotom Icc 200
Summary page 1
…eurological Devices Product Code: GEl Class: H Predicate Device Information: Canady Technology, LLC Canady Plasma Probes for Flexible Endoscopy - K05203 5 ERBE ICC 200 -K933157 ERBE VIO 300D - K023886 ERLBE VIG APC2 - K024047 ERBE APC Applications - KO 13348 Valley Lab Force FX - K944602 BOVIE IDS-300 K02…
Erbe USA, Inc.1994—
*K023886Erbe Vio Esu with Accessories, Model Vio 300 D
Summary page 1
…uct Code: GEl Class: H Predicate Device Information: Canady Technology, LLC Canady Plasma Probes for Flexible Endoscopy - K05203 5 ERBE ICC 200 -K933157 ERBE VIO 300D - K023886 ERLBE VIG APC2 - K024047 ERBE APC Applications - KO 13348 Valley Lab Force FX - K944602 BOVIE IDS-300 K022856 D…
Erbe USA, Inc.2002—
*K024047Erbe Vio Apc with Accessories
Summary page 1
…redicate Device Information: Canady Technology, LLC Canady Plasma Probes for Flexible Endoscopy - K05203 5 ERBE ICC 200 -K933157 ERBE VIO 300D - K023886 ERLBE VIG APC2 - K024047 ERBE APC Applications - KO 13348 Valley Lab Force FX - K944602 BOVIE IDS-300 K022856 Device Description: The…
Erbe USA, Inc.2003—
*K013348Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…Erbe USA, Inc.2001—
*K944602Valleylab Force FX
Summary page 1
…ma Probes for Flexible Endoscopy - K05203 5 ERBE ICC 200 -K933157 ERBE VIO 300D - K023886 ERLBE VIG APC2 - K024047 ERBE APC Applications - KO 13348 Valley Lab Force FX - K944602 BOVIE IDS-300 K022856 Device Description: The Canady PlasmJ~m Electrosurgical Unit Series with Accessories is…
Valleylab, Inc.1995—
*K022856Bovie Ids-300 High Frequency Electrosurgical Generator
Summary page 1
…Endoscopy - K05203 5 ERBE ICC 200 -K933157 ERBE VIO 300D - K023886 ERLBE VIG APC2 - K024047 ERBE APC Applications - KO 13348 Valley Lab Force FX - K944602 BOVIE IDS-300 K022856 Device Description: The Canady PlasmJ~m Electrosurgical Unit Series with Accessories is an H~§h Frequency (…
Aaron Medical Industries2003—

Also cleared against K052035: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC20191

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 22 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
  • None of the 13 ancestors has a recall.
  • Of its descendants, K192124 (Us Medical Innovations, LLC, 2019) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K052035.

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. 2011, 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 Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.

The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.

Indications for use as stated in the FDA summary.

Also cleared against K052035

1 other device cites the same predicate.

  • K081644Beamer Argon ProbeConmed Corporation · 2008

More from Us Medical Innovations, LLC

5 FDA decisions under this applicant name. See the company

  • K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024
  • K212736Canady Flex RoboWristUs Medical Innovations, LLC · 2022
  • K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019
  • K113500Canady Vieira Hybrid Plasma ScalpelUs Medical Innovations, LLC · 2011

Recent decisions in GEI

The GEI category page

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https://510kreport.com/device/K100669 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100669: Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100669

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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