510(k) · Cleared
Recalled · Class II · 2012Aem Disposable Electrodes,Model ESO300 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encision, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 17, 2009 after a 125-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 9 times.
- Decided
- Aug 17, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 9
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK091074 Aem Disposable Electrodes,Model ESO300 SeriesEncision, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK191612 Encision AEM Monopolar Laparoscopic Instruments and AccessoriesEncision Incorporated · 2020
- Descendant · cites it directly · 1 of its ownK122580 Aem Disposable Suction Irrigation Handset Model ES1700; Aem…Encision, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK201018 Encision AEM enTouch 2X ScissorEncision, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK131949 Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K191612Encision AEM Monopolar Laparoscopic Instruments and AccessoriesEncision Incorporated · 2020 · cites it directly1descendant
- K122580Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction…Encision, Inc. · 2012 · cites it directly1descendant
- K201018Encision AEM enTouch 2X ScissorEncision, Inc. · 2020 · 2 generations on0descendants
- K131949Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091074 | Aem Disposable Electrodes,Model ESO300 Series | Encision, Inc. | 2009 | — |
| +1 | K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | Encision Incorporated | 2020 | — |
| +1 | K122580 | Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction… | Encision, Inc. | 2012 | — |
| +2 | K201018 | Encision AEM enTouch 2X Scissor | Encision, Inc. | 2020 | — |
| +2 | K131949 | Aem Disposable Suction Irrigation Electrodes | Encision, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Model ES0300 series AEM Disposable Electrodes Named without a submission number |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Jun 15, 2012 | Class II | Z-1951-2012 | Device Design | Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during… |
| Apr 5, 2010 | Not classified | Z-1540-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1546-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1541-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1544-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1542-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1545-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1539-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
| Apr 5, 2010 | Not classified | Z-1543-2010 | Nonconforming Material/Component | Electrosurgical electrode tip insulation may crack and break off during use. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K191612 (Encision Incorporated, 2020) has gone furthest, with 1 descendant 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. 2009, 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?
AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical
accessories intended, by use of monopolar high-frequency electrical current from
compatible electrosurgical generators, for ablation, removal, resection and coagulation of
soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic
surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of
electrosurgical equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091074: Aem Disposable Electrodes,Model ESO300 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091074
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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