510(k) Report

510(k) · Cleared

Cleared

Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments

K042604510(k) SpecialCleared Oct 22, 200428-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

Valley Forge Scientific Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 22, 2004 as substantially equivalent to K910510 (Valley Forge Scientific Corp., 1991) and 7 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1985.

Decided
Oct 22, 2004
Review
28 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K850297 (1985). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1997: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestorK850297 · Electrosurgical Pencil Holder 720 · Birtcher Corp. · 198519851990199520002005
Other ancestors, by generation 1 generation back: 7 other ancestors K850297 · Electrosurgical Pencil Holder 720 · Birtcher Corp. · 19850
  1. Root · 1 generation backK850297 Electrosurgical Pencil Holder 720Birtcher Corp. · 1985
  2. This deviceK042604 Vally Forge Scientific Malis Bipolar Disposable Finger Operated…Valley Forge Scientific Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850297Electrosurgical Pencil Holder 720Birtcher Corp.1985—
0 (this device)K042604Vally Forge Scientific Malis Bipolar Disposable Finger Operated…Valley Forge Scientific Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199410
199610
199710
199820
FIG. 1 — Lineage of K042604, 1985–2004Source: 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? (8)

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
*K910510Valley Forge Bipolar Pen or Forceps
Summary page 1
…lassification: This device is Class 11per CFR § 878.4400- Electrosurgical Cutting and Coagulation Instruments Predicate Devices: K91 0510 Valley Forge Scientific Corp. K896626 Conmed Corp. K955764 Valley Forge Scientific Corp.…
Valley Forge Scientific Corp.1991—
*K896626Hand Controlled Electrosurgical Pencils
Summary page 1
…§ 878.4400- Electrosurgical Cutting and Coagulation Instruments Predicate Devices: K91 0510 Valley Forge Scientific Corp. K896626 Conmed Corp. K955764 Valley Forge Scientific Corp. K982742 New Deantronics' K973554…
Conmedcorp1990—
*K955764Valley Forge Biploar Loop
Summary page 1
…Electrosurgical Cutting and Coagulation Instruments Predicate Devices: K91 0510 Valley Forge Scientific Corp. K896626 Conmed Corp. K955764 Valley Forge Scientific Corp. K982742 New Deantronics' K973554 Valley Forge Scientific Corp.…
Valley Forge Scientific Corp.1996—
*K982742Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models…
Summary page 1
…nstruments Predicate Devices: K91 0510 Valley Forge Scientific Corp. K896626 Conmed Corp. K955764 Valley Forge Scientific Corp. K982742 New Deantronics' K973554 Valley Forge Scientific Corp. K982884 New Deantronics K932345…
New Deantronics Taiwan, Ltd.1998—
*K973554Valley Forge Bipolar Ball Tip Electrode
Summary page 1
…10 Valley Forge Scientific Corp. K896626 Conmed Corp. K955764 Valley Forge Scientific Corp. K982742 New Deantronics' K973554 Valley Forge Scientific Corp. K982884 New Deantronics K932345 Conmed Corp.…
Valley Forge Scientific Corp.1997—
*K982884Disposable Hand Switching Pencil, Rocker Switch Two Piece, SB 312RS, Two Disposable Hand…
Summary page 1
…6 Conmed Corp. K955764 Valley Forge Scientific Corp. K982742 New Deantronics' K973554 Valley Forge Scientific Corp. K982884 New Deantronics K932345 Conmed Corp. K850297 Birtcher Corp. Intended Use:…
New Deantronics, Ltd.1998—
*K932345Tech-Switch Electrosurgical Pencil, Single Use
Summary page 1
…Valley Forge Scientific Corp. K982742 New Deantronics' K973554 Valley Forge Scientific Corp. K982884 New Deantronics K932345 Conmed Corp. K850297 Birtcher Corp. Intended Use: The Valley Forge Scientific MaliSTm…
Conmedcorp1994—
*K850297Electrosurgical Pencil Holder 720
Summary page 1
…New Deantronics' K973554 Valley Forge Scientific Corp. K982884 New Deantronics K932345 Conmed Corp. K850297 Birtcher Corp. Intended Use: The Valley Forge Scientific MaliSTm Bipolar Disposable Electro- Surgical Pen is indicate…
Birtcher Corp.1985—

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?

  • None of the 8 ancestors has a recall.

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?

Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and control of bleeding in surgical procedures using high frequency (RF) current.

Indications for use as stated in the FDA summary.

More from Valley Forge Scientific Corp.

27 FDA decisions under this applicant name. See the company

  • K050364Malis 2000 Bipolar Electrosurgical SystemValley Forge Scientific Corp. · 2005
  • K032601Stryker Interventional Pain RF GeneratorValley Forge Scientific Corp. · 20041 recall
  • K033499Malis Irrigation Module 1000Valley Forge Scientific Corp. · 2003
  • K982229BI-DentValley Forge Scientific Corp. · 1998
  • K973554Valley Forge Bipolar Ball Tip ElectrodeValley Forge Scientific Corp. · 1997

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The GEI category page

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https://510kreport.com/device/K042604 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042604: Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042604

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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