510(k) · Cleared
ClearedAem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015
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 20, 2010 as substantially equivalent to K913625 (Electroscope, Inc., 1991) and 1 other predicate after a 270-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Aug 20, 2010
- Review
- 270 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913625 (1991). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913625 Electroscope Monitor, EM-1Electroscope, Inc. · 1991 · Recalled
- This deviceK093622 Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and…Encision, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK122383 EM3 Aem Monitor Aem ConnectorsEncision, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK140006 Endoshield Burn Protection SystemEncision, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913625 | Electroscope Monitor, EM-1 | Electroscope, Inc. | 1991 | 1 |
| 0 (this device) | K093622 | Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015 | Encision, Inc. | 2010 | — |
| +1 | K122383 | EM3 Aem Monitor Aem Connectors | Encision, Inc. | 2013 | — |
| +2 | K140006 | Endoshield Burn Protection System | Encision, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K913625 | Electroscope Monitor, EM-1Summary page 1…toring (AEM) System Encision Inc. Regulatorv Background: The AEM Monitor, under the name Electroscope Monitor EM-I1, received 5 10(k) premarket clearance via K913625 on December 30, 199 1. The AEM Monitoring System, including the AEM Monitor, was modified for use with non-CQM patient return ele… | 1991 |
| * | K072789 | Disposable Aem Fixed Tip Electrodes and HandpiecesSummary page 1…30, 199 1. The AEM Monitoring System, including the AEM Monitor, was modified for use with non-CQM patient return electrodes and received 5 10(k) premarket clearance via K072789 on May 2, 2000. However, this version is no longer marketed. Reason for Submission: The purpose of this submission is to specify… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122383 | EM3 Aem Monitor Aem Connectors | 2013 | 1 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122383 (Encision, Inc., 2013) 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. 2010, 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?
The Encision AEM Monitoring System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.
The AEM Monitoring System consists of two distinct functions:
* Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
* End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093622: Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093622
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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