# K913625: Electroscope Monitor, EM-1

- Pathway: 510(k) (Traditional)
- Applicant: Electroscope, Inc.
- Decided: Dec 30, 1991 after 137 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093622: Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015 (2010), 2 descendants of its own
- K122383: EM3 Aem Monitor Aem Connectors (2013), 1 descendant of its own
- K140006: Endoshield Burn Protection System (2014), 0 descendants of its own

## Recalls of this device
- Jul 9, 2004 · Not classified · Z-1132-04: Firm found pinholes in packaging which would compromise sterility.

Source page: https://510kreport.com/device/K913625
Methodology: https://510kreport.com/methodology