# K971184: Oxi-Snap

- Pathway: 510(k) (Traditional)
- Applicant: Snap Laboratories, LLC
- Decided: Oct 1, 1997 after 183 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 K944524 (1995). 1 ancestor in all.
5 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)
- K944524: Snap Testing Device, Snap Laboratories, LLC (1995) Summary page 1.

## Most influential descendants
- K984169: Digi-Snap (1999), 4 descendants of its own
- K992322: Snap Model 5 (2000), 3 descendants of its own
- 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 "Oxi-Snap" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The Oxi-SNAP testing system is only intended for short term monitoring such as to record the oximetry level continuously during the night. The "Oxi-SNAP" 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.

Source page: https://510kreport.com/device/K971184
Methodology: https://510kreport.com/methodology