# K992322: Snap Model 5

- Pathway: 510(k) (Traditional)
- Applicant: Snap Laboratories, LLC
- Decided: Feb 2, 2000 after 205 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: 3 generations back to K944524 (1995). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984169: Digi-Snap, Snap Laboratories, LLC (1999) Summary page 1.

## Most influential descendants
- K080321: Snap Model 7 Snoring and Apnea Recording and Analysis System (2008), 2 descendants of its own
- 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 intended use of the “"Snap Model 5™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The "Snap Model 5™" testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required. The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to 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 5™" device.

Source page: https://510kreport.com/device/K992322
Methodology: https://510kreport.com/methodology