# K080321: Snap Model 7 Snoring and Apnea Recording and Analysis System

- Pathway: 510(k) (Special)
- Applicant: Snap Laboratories, LLC
- Decided: May 23, 2008 after 107 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: 4 generations back to K944524 (1995). 5 ancestors in all.
2 later devices descend 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)
- K002095: Snap Model 6, Snap Laboratories, LLC (2001) Summary page 1.
- K992322: Snap Model 5, Snap Laboratories, LLC (2000) Summary page 1.

## Most influential descendants
- K110064: Snap Model 8 Snoring and Apnea Recording and Analysis System (2011), 1 descendant of its own
- K240100: SAM Model 9-10000 (2024), 0 descendants of its own

## Indications for use
The SNAP Model 7TM 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 Model 7TM testing system is not intended as a substitute for full polysomnography 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. CAUTION: US Federal law restricts this device to sale by or on the order of a physician. Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the SNAP Model 7TM device.

Source page: https://510kreport.com/device/K080321
Methodology: https://510kreport.com/methodology