510(k) · Cleared
Recalled · 2009E-Z Clean Electrosurgical Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 21, 2008 as substantially equivalent to K862221 (American Medical Products, Inc., 1986) and 1 other predicate after a 118-day review. Its family tree reaches back 2 generations to 1978. 8 later devices descend from it. It has been recalled once.
- Decided
- Oct 21, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K780977 (1978). 5 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK780977 Single Use Blade ElectrodeAspen Laboratories, Inc. · 1978
- 1 generation backK960255 Ceramic Blade ElectrodeUtah Medical Products, Inc. · 1996
- This deviceK081791 E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK091672 Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK220725 HPR45iF Care Systems USA, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK152059 Disposable General ElectrodeModern Medical Equipment Manufacturing Limited · 2016
- Descendant · 2 generations on · 0 of its ownK252704 F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE…F Care Systems USA, LLC · 2025
- Descendant · cites it directly · 0 of its ownK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091672Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd. · 2009 · cites it directly3descendants
- K220725HPR45iF Care Systems USA, LLC · 2023 · cites it directly1descendant
- K152059Disposable General ElectrodeModern Medical Equipment Manufacturing Limited · 2016 · 2 generations on1descendant
- K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC · 2025 · 2 generations on0descendants
- K240868Ultravision2™ IonPencilAlesi Surgical Limited · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780977 | Single Use Blade Electrode | Aspen Laboratories, Inc. | 1978 | — |
| −1 | K960255 | Ceramic Blade Electrode | Utah Medical Products, Inc. | 1996 | — |
| 0 (this device) | K081791 | E-Z Clean Electrosurgical Electrode | Megadyne Medical Products, Inc. | 2008 | — |
| +1 | K091672 | Disposable Grounding Pad Series and Electrode Series | Shuyou Electric Medical Science Co., Ltd. | 2009 | — |
| +1 | K220725 | HPR45i | F Care Systems USA, LLC | 2023 | — |
| +2 | K152059 | Disposable General Electrode | Modern Medical Equipment Manufacturing Limited | 2016 | — |
| +2 | K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB… | F Care Systems USA, LLC | 2025 | — |
| +1 | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862221 | E-Z CleanSummary page 2…and accessories E. PredicateDevices The predicate devices include American Medical Products' E-Z Clean Cautery Tip which was cleared for marketing via 510(k) # K862221 by FDA's Office of Device Evaluation on August 11, 1986; and Utah Medical Products' Epitome® Scalpel electrode with ZapGuar… | 1986 |
| * | K960255 | Ceramic Blade ElectrodeSummary page 2…Office of Device Evaluation on August 11, 1986; and Utah Medical Products' Epitome® Scalpel electrode with ZapGuardT M which was cleared for marketing via 510(k) #K960255 on March 27, 1996. F. Applicant Device Description The Megadyne E-Z Clean electrosurgical electrode is a monopolar elect… | 1996 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2009 | Not classified | Z-0486-2010 | Error in labeling | Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K091672 (Shuyou Electric Medical Science Co., Ltd., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF)
current for cutting and coagulation from the RE electrosurgical generator to target
soft tissue in a broad range of surgical procedures requiring the use of
electrosurgery for cutting and cauterization.
Some tip configurations have a specific geometry that minimizes blanching and
thermal damage in skin incisions when used in conjunction with the generator's
Advanced Cutting Effect (ACE) mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081791: E-Z Clean Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081791
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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