510(k) Report

510(k) · Cleared

Cleared

System 7500 Abc Electrosurgical Unit

K981220510(k) TraditionalCleared Apr 21, 199818-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

Aspen Laboratories, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 21, 1998 after an 18-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Apr 21, 1998
Review
18 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2002: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981220 System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1998
  2. Descendant · cites it directly · 4 of its ownK050161 System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible…Conmed Electrosurgery · 2005
  3. Descendant · 2 generations on · 3 of its ownK152860 Helixar Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2015
  4. Descendant · 3 generations on · 2 of its ownK172671 HelixAR Electrosurgical Generator with Argon Beam Coagulation…Conmed Corporation · 2017
  5. Descendant · 4 generations on · 0 of its ownK213354 Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify…Conmed Corporation · 2022
  6. Descendant · 4 generations on · 0 of its ownK203522 Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12005: 12015: 12017: 12021: 12022: 1
2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K050161System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible EndoscopyConmed Electrosurgery · 2005 · cites it directly4descendants
  • K152860Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile PedestalConmed Corporation · 2015 · 2 generations on3descendants
  • K172671HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile PedestalConmed Corporation · 2017 · 3 generations on2descendants
  • K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation · 2022 · 4 generations on0descendants
  • K203522Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation · 2021 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981220System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc.1998—
+1K050161System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible EndoscopyConmed Electrosurgery2005—
+2K152860Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile…Conmed Corporation2015—
+3K172671HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile…Conmed Corporation2017—
+4K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar…Conmed Corporation2022—
+4K203522Surn5 Electrosurgical Argon Beam Generator and AccessoriesSurnic Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
201510
201710
202110
202210
FIG. 1 — Lineage of K981220, 1998–2022Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K050161System 7500-B Electrosurgical Unit; Abcflex Probe for Flexible EndoscopyConmed Electrosurgery20054
K014172Nelson Electrosurgical Unit, Model GN640Aesculap, Inc.20020

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?

  • Of its descendants, K050161 (Conmed Electrosurgery, 2005) has gone furthest, with 4 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—

What is it indicated for?

Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Aspen Laboratories, Inc.

55 FDA decisions under this applicant name. See the company

  • K963088Sheath, Electrosurgical PencilAspen Laboratories, Inc. · 19965 recalls
  • K955834System 6500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1996
  • K9602964000 ETMAspen Laboratories, Inc. · 1996
  • K953081Beamer PlusAspen Laboratories, Inc. · 1995
  • K953007Excalibur Plus Electrosurgical UnitAspen Laboratories, Inc. · 1995

Recent decisions in GEI

The GEI category page

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  • 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/K981220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981220: System 7500 Abc Electrosurgical Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981220

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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