# K110064: Snap Model 8 Snoring and Apnea Recording and Analysis System

- Pathway: 510(k) (Special)
- Applicant: Snap Diagnostics, LLC
- Decided: Mar 18, 2011 after 67 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: 5 generations back to K944524 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080321: Snap Model 7 Snoring and Apnea Recording and Analysis System, Snap Laboratories, LLC (2008) Summary page 1.

## Most influential descendants
- K240100: SAM Model 9-10000 (2024), 0 descendants of its own

## Indications for use
The SNAP ModelS8 device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The SNAP ModelS8 system is not intended as a substitute for full polysamnography when additional parameters such as sleep stages or EEG activity are required. The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.

Source page: https://510kreport.com/device/K110064
Methodology: https://510kreport.com/methodology