# K240100: SAM Model 9-10000

- Pathway: 510(k) (Traditional)
- Applicant: Snap Diagnostics, LLC
- Decided: Jun 4, 2024 after 144 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: 6 generations back to K944524 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110064: Snap Model 8 Snoring and Apnea Recording and Analysis System, Snap Diagnostics, LLC (2011) Summary page 5.

## Indications for use
The SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring. The SNAP Diagnostics SAM Model 9-10000 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. 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 Diagnostics SAM Model 9-10000 device.

Source page: https://510kreport.com/device/K240100
Methodology: https://510kreport.com/methodology