# K093622: Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Aug 20, 2010 after 270 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913625 (1991). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913625: Electroscope Monitor, EM-1, Electroscope, Inc. (1991) Summary page 1.
- K072789: Disposable Aem Fixed Tip Electrodes and Handpieces, Encision, Inc. (2007) Summary page 1.

## Most influential descendants
- K122383: EM3 Aem Monitor Aem Connectors (2013), 1 descendant of its own
- K140006: Endoshield Burn Protection System (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K093622
Methodology: https://510kreport.com/methodology