# K220631: NomadAir PMU810

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: Jul 15, 2022 after 133 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- 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 K092699 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092699: Nomad Sleep System Recorder, Model PMU800, Neurotronics, Inc. (2010) Summary page 5.

## Most influential descendants
- K223676: SomniCheck (2023), 0 descendants of its own

## Indications for use
The NomadAir PMUS810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMUS810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMUS810 is intended for use on adults only under the direction of a physician or qualified sleep technician. The NomadAir PMUS810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, * an alarm or alarm system; * an apnea monitor or apnea monitoring system; or * a life monitor or life monitoring system.

Source page: https://510kreport.com/device/K220631
Methodology: https://510kreport.com/methodology