# K160613: Soberlink Cellular Device and Sober Sky Web Portal

- Pathway: 510(k) (Traditional)
- Applicant: Soberlink Healthcare, LLC
- Decided: Jul 14, 2016 after 133 days
- Product code: DJZ (Devices, Breath Trapping, Alcohol)
- Device class: 1
- Regulation: 21 CFR 862.3050
- 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 K041334 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123470: Pas Alcovisor Mars, Pas Alcovisor Satellite, Pas Systems International, Inc. (2013) Summary page 4.

## Indications for use
The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath. Measurements obtained by this Device are used in the diagnosis of alcohol intoxication.

Source page: https://510kreport.com/device/K160613
Methodology: https://510kreport.com/methodology