# K260050: WRAP System

- Pathway: 510(k) (Traditional)
- Applicant: Huneo, LLC
- Decided: Jul 15, 2026 after 189 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210593: Onera Sleep Test System (Onera STS), Onera B.V. (2022) Summary page 5.
- K934599: Sandman, Melville Software, Ltd. (1994) Summary page 5.
- K153412: Sleep Profiler, Advanced Brain Monitoring, Inc. (2016) Summary page 5.

## Indications for use
The Wireless Realtime Attended Polysomnogram (WRAP) System measures and records multiple physiological parameters from a patient during a sleep study and its autoscoring algorithm scores sleep stages automatically. These recorded physiological parameters are used by clinicians to assist in evaluating the diagnosis of sleep disorders. The WRAP System is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults.

Source page: https://510kreport.com/device/K260050
Methodology: https://510kreport.com/methodology