Which medical device would NOT be reviewed by CDRH's Office of Device Evaluation in a 510(k) Premarket Notification?

The correct answer indicates that the blood specimen collection device would not be reviewed by the Center for Devices and Radiological Health (CDRH) Office of Device Evaluation in a 510(k) Premarket Notification. This is because the blood specimen collection devices are generally categorized as Class I devices, which often have very few regulatory requirements. Many Class I devices are exempt from the 510(k) process entirely, meaning that manufacturers can market these products without prior safety and efficacy data submission and without review by the CDRH.

In contrast, devices like high flux hemodialyzers, piston syringes, and cardiopulmonary bypass blood tubing are typically classified as Class II or III devices. These classifications require a more thorough review process, including submission of a 510(k) for evidence of substantial equivalence to a legally marketed device. Such devices often pose greater risks or complexities and therefore necessitate more stringent review mechanisms by the CDRH.