510(k) · Cleared
ClearedEM3 Aem Monitor Aem Connectors
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 Jan 10, 2013 as substantially equivalent to K093622 (Encision, Inc., 2010) after a 157-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Jan 10, 2013
- Review
- 157 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913625 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK913625 Electroscope Monitor, EM-1Electroscope, Inc. · 1991 · Recalled
- 1 generation backK093622 Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and…Encision, Inc. · 2010
- This deviceK122383 EM3 Aem Monitor Aem ConnectorsEncision, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140006 Endoshield Burn Protection SystemEncision, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140006Endoshield Burn Protection SystemEncision, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913625 | Electroscope Monitor, EM-1 | Electroscope, Inc. | 1991 | 1 |
| −1 | K093622 | Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015 | Encision, Inc. | 2010 | — |
| 0 (this device) | K122383 | EM3 Aem Monitor Aem Connectors | Encision, Inc. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K093622 | Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015Summary page 1…Product Code: GET) Predicate Device Trade Names EM2 AEM Monitor Market Clearance 5110(k): K093622 (2010) __ Common name Electrosurgical, Cutting & Coaguilatio &… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140006 | Endoshield Burn Protection System | 2014 | 0 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 18.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140006 (Encision, Inc., 2014) has gone furthest, with 0 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. 2013, 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 EM3 AEM Monitor 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 EM3 AEM Monitor performs 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/K122383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122383: EM3 Aem Monitor Aem Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122383
Report an extraction error
Are you the manufacturer?
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