# K100879: Contralco

- Pathway: 510(k) (Traditional)
- Applicant: Contralco
- Decided: Aug 4, 2010 after 127 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: 1 generation back to K072953 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072953: Redline Alcohol Breath Tester, Redline Products (Pty), Ltd. (2008) Summary page 1.

## Indications for use
The Contralco Alcohol Breath Tester is an in vitro medical device to semi-quantitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs: 0.02, 0.04, 0.05, 0.06, 0.08, and 0.10 relative percent Blood Alcohol Concentration (BAG). The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.

Source page: https://510kreport.com/device/K100879
Methodology: https://510kreport.com/methodology