# K183625: SomnaPatch

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Oct 18, 2019 after 296 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: 1 generation back to K090484 (2009). 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)
- K090484: Alice PDX, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 4.

## Indications for use
The SomnaPatch™ is a single use physiologic recorder intended to collect and record data for use by clinical software used in polysomnography and sleep disorder studies by providing the information required for calculation of the apnea-hypopnea index. It is intended for adult use and can be used in a hospital, clinic, or patient home.

Source page: https://510kreport.com/device/K183625
Methodology: https://510kreport.com/methodology