DeviceClearance

Product code PPW— Cardiovascular

CipherOx CRI Tablet

Classification name
Adjunctive Cardiovascular Status Indicator
Device class
Class 2
Regulation
21 CFR 870.2200
Advisory panel
Cardiovascular
Total cleared
8
First cleared
Most recent

FDA classification definition

“The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.”

— U.S. Food and Drug Administration, device classification record for product code PPW under 21 CFR 870.2200, via openFDA

Market context for product code PPW

FDA has cleared 8 devices under product code PPW between 2016 and 2026, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code PPW

Recent clearances under product code PPW

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