# K203343: Wesper Lab

- Pathway: 510(k) (Traditional)
- Applicant: Wesper, Inc.
- Decided: Dec 21, 2021 after 403 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: 7 generations back to K913396 (1992). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122516: Embletta MPR, Embla Systems (2013) Summary page 4.

## Most influential descendants
- K221816: Wesper Lab (2023), 0 descendants of its own

## Indications for use
The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. Wesper Lab is intended to be used for adult sleep studies at home or clinical environment. The body-worn component of the system is single-use, to be discarded after its dedicated nightly application. The device does not monitor or diagnose the patient and does not issue any alarms.

Source page: https://510kreport.com/device/K203343
Methodology: https://510kreport.com/methodology