# K020955: Nicolet Electrocautery Detector

- Pathway: 510(k) (Abbreviated)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Apr 17, 2002 after 23 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- 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 K934426 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934426: Nerve Integrity Monitor-2 (Nim-2 XL), Xomed-Treace, Inc. (1994) Summary page 1.

## Indications for use
The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

Source page: https://510kreport.com/device/K020955
Methodology: https://510kreport.com/methodology