510(k) Report

510(k) · Cleared

Recalled · 2010

Single Use Monopolar Hand Control Pencil

K791137510(k) TraditionalCleared Jul 24, 197936-day reviewClass II21 CFR 878.4400Recalls 12

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Davol, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 24, 1979 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled 12 times.

Decided
Jul 24, 1979
Review
36 days
Class
Class II
Product code
GEI
Recalls
12
Predicates
0

10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2014: 3 descendants cleared2016: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979
  2. Descendant · cites it directly · 9 of its ownK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
  3. Descendant · 2 generations on · 8 of its ownK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
  4. Descendant · 3 generations on · 5 of its ownK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
  5. Descendant · 3 generations on · 4 of its ownK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
  6. Descendant · 4 generations on · 3 of its ownK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12012: 12014: 32015: 12016: 22018: 12026: 1
2008high 3 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K081634Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008 · cites it directly9descendants
  • K120454Safeair Smoke Pencil,Lna Medical Aps · 2012 · 2 generations on8descendants
  • K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on5descendants
  • K143145SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on4descendants
  • K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K791137Single Use Monopolar Hand Control PencilDavol, Inc.1979—
+1K081634Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation2008—
+2K120454Safeair Smoke Pencil,Lna Medical Aps2012—
+3K142538LiNA SafeAir Smoke PencilLina Medical Aps2014—
+3K143145SafeAir Smoke PencilLina Medical Aps20148
+4K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201210
201430
201510
201620
201810
202610
FIG. 1 — Lineage of K791137, 1979–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K081634Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation20089
K143103PROPENCIL Smoke PencilBio Protech, Inc.20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 29, 2010Not classifiedZ-1566-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1563-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1567-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1568-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1572-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1569-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1564-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1570-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1573-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1562-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1571-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.
Mar 29, 2010Not classifiedZ-1565-2010Device DesignElectrosurgical pencil may remain activated or self activate after power switch is released.

The 5 latest of 12 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K081634 (Conmed Corporation, 2008) has gone furthest, with 9 descendants of its own.

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—

More from Davol, Inc.

91 FDA decisions under this applicant name. See the company

  • P050038/S044Arista™ AHDavol, Inc. · 2026
  • P050038/S043Arista™ AHDavol, Inc. · 2026
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025
  • K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc. · 2025
  • P050038/S042Arista AHDavol, Inc. · 2024

Recent decisions in GEI

The GEI category page

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https://510kreport.com/device/K791137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791137: Single Use Monopolar Hand Control Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791137

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026