# K102114: Medrange Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Medrange Corporation
- Decided: Nov 22, 2010 after 117 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 K944602 (1995). 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)
- K953007: Excalibur Plus Electrosurgical Unit, Aspen Laboratories, Inc. (1995) Summary page 1.
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.

## Most influential descendants
- K201224: Electrosurgical Generator and Accessories (2020), 1 descendant of its own
- K253777: Ascblue (8010) (2026), 0 descendants of its own

## Indications for use
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.

Source page: https://510kreport.com/device/K102114
Methodology: https://510kreport.com/methodology