Redline Products (Pty), Ltd.

Redline Products specializes in manufacturing the REDLINE Alcohol Breath Tester, a portable device used to measure alcohol concentration in a person’s breath for on-site impairment assessment. This device falls under the category of diagnostic tools designed to aid in evaluating alcohol-related impairment.

Redline Products is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as its devices are subject to US medical device regulations.

The REDLINE Alcohol Breath Tester is classified as a Class I medical device in the US. This classification is typically assigned to devices posing minimal risk to users, such as general-purpose surgical instruments or low-risk diagnostic tools. Class I devices often undergo less stringent regulatory scrutiny but still require compliance with applicable safety and performance standards.

The REDLINE Alcohol Breath Tester is listed under the FDA’s 510(k) pathway, a premarket submission required for most Class I devices that are not exempt. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and effectiveness requirements before commercial distribution.