# K242290: DormoTech NLab

- Pathway: 510(k) (Traditional)
- Applicant: Dormotech Medical, Ltd.
- Decided: Jan 8, 2025 after 159 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 K910772 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082113: Nox T3, Noxturnal (PC Application), Nox Medical (2008) Summary page 5.
- K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420, Dolphin Medical, Inc. (2004) Summary page 5.

## Indications for use
The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments.

Source page: https://510kreport.com/device/K242290
Methodology: https://510kreport.com/methodology