DeviceClearance

Product code PRK— Anesthesiology

ReDe Mask

Classification name
Device Indicating An Exhalation Event
Device class
Class 2
Regulation
21 CFR 868.2375
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To provide visual indication of each exhalation event”

— U.S. Food and Drug Administration, device classification record for product code PRK under 21 CFR 868.2375, via openFDA

Market context for product code PRK

FDA has cleared 1 device under product code PRK, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PRK

Recent clearances under product code PRK

Data sourced from openFDA. This site is unofficial and independent of the FDA.