# K172711: Comet-PLUS

- Pathway: 510(k) (Special)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Nov 3, 2017 after 56 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000068 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021807: Grass-Telefactor AS40 Amplifier System, Grass Instrument Co. (2002) Summary page 4.

## Most influential descendants
- K180290: Natus Brain Monitor Amplifier (2018), 1 descendant of its own
- K193159: NeuroAmp II, NeuroAmp II.5s (2020), 0 descendants of its own

## Indications for use
The Comet-PLUS® is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

Source page: https://510kreport.com/device/K172711
Methodology: https://510kreport.com/methodology