510(k) Report

510(k) · Cleared

Cleared

Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft

K202962510(k) TraditionalCleared Nov 20, 202051-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

New Deantronics Taiwan, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 20, 2020 as substantially equivalent to K182772 (Covidien, 2018) after a 51-day review. Its family tree reaches back 3 generations to 1994.

Decided
Nov 20, 2020
Review
51 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K936304 (1994). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1995: 1 other ancestorK936304 · Electrosurgical Pencil · E & M Engineering, Inc. · 1994 · recalledK103375 · Plumepen Integrated Smoke Evacuation Pencil · Medtek Devices, Inc. · 2011K182772 · Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil · Covidien · 20181990199520002005201020152020
Other ancestors, by generation 3 generations back: 2 other ancestors K182772 · Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil · Covidien · 2018K103375 · Plumepen Integrated Smoke Evacuation Pencil · Medtek Devices, Inc. · 2011K936304 · Electrosurgical Pencil · E & M Engineering, Inc. · 1994 · recalled0
  1. Root · 3 generations backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
  2. 2 generations backK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
  3. 1 generation backK182772 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab…Covidien · 2018
  4. This deviceK202962 Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke…New Deantronics Taiwan, Ltd. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K936304Electrosurgical PencilE & M Engineering, Inc.19943
−2K103375Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc.2011—
−1K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke…Covidien2018—
0 (this device)K202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation…New Deantronics Taiwan, Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010
FIG. 1 — Lineage of K202962, 1994–2020Source: 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
*K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…
Summary page 4
…Covidien (formerly Valleylab, Inc.) Predicate Device Common Name: Electrosurgical Accessory - Electrode Predicate Device Premarket Notification # K182772 Predicate Device Classification: 21 CFR 878.4400 Electrosurgical, Cu…
Covidien2018—

Also cleared against K182772: 2 other devices →

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 26 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K182772.

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. 2020, 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 Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Button Switch Pencil are intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The Pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Indications for use as stated in the FDA summary.

Also cleared against K182772

2 other devices cite the same predicate.

  • K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke…Covidien, LLC · 2024
  • K220996DuobladeCnc Technologies · 2023

More from New Deantronics Taiwan, Ltd.

19 FDA decisions under this applicant name. See the company

  • K251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan, Ltd. · 2026
  • K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025
  • K201221Electrosurgical GeneratorNew Deantronics Taiwan, Ltd. · 2020
  • K200455Trigger Switch and CordNew Deantronics Taiwan, Ltd. · 2020
  • K193004Monopolar CordNew Deantronics Taiwan, Ltd. · 2019

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/K202962 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202962: Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202962

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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