510(k) Report

510(k) · Cleared

Cleared

Nessy (Omega) Disposable Split Return Electrodes, Models P/N: 20193-084 and P/N: 20193-085

K023812510(k) SpecialCleared Nov 29, 200214-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

Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 29, 2002 as substantially equivalent to K972269 (Erbe USA, Inc., 1997) after a 14-day review. Its family tree reaches back 1 generation to 1997.

Decided
Nov 29, 2002
Review
14 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K972269 (1997). No later device cites it as a predicate yet.

K972269 · Disposable Patient Return Electrode · Erbe USA, Inc. · 199719961998200020022004
K972269 · Disposable Patient Return Electrode · Erbe USA, Inc. · 19970
  1. Root · 1 generation backK972269 Disposable Patient Return ElectrodeErbe USA, Inc. · 1997
  2. This deviceK023812 Nessy (Omega) Disposable Split Return Electrodes, Models P/N…Erbe USA, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972269Disposable Patient Return ElectrodeErbe USA, Inc.1997—
0 (this device)K023812Nessy (Omega) Disposable Split Return Electrodes, Models P/N: 20193-084 and…Erbe USA, Inc.2002—
FIG. 1 — Lineage of K023812, 1997–2002Source: 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
*K972269Disposable Patient Return Electrode
Summary page 1
…ccessories (21CFR878.4400) Product Code: 79GEI Leaallv Marketed Device: ERBE Disposable Patient Return Electrodes, 51O(k) Number: K972269 Device Description: There are two models of the NESSY QTM (Omega) Disposable Split Return Electrode. One with a connecting cabl…
Erbe USA, Inc.1997—

Also cleared against K972269: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K972269.

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?

NESSY QTM (Omega) disposable split return electrodes are intended for

dispersing and monitoring HF current in electrosurgical interventions.

Indications for use as stated in the FDA summary.

Also cleared against K972269

1 other device cites the same predicate.

  • K030362Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003

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https://510kreport.com/device/K023812 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023812: Nessy (Omega) Disposable Split Return Electrodes, Models P/N: 20193-084 and P/N: 20193-085.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023812

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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