DeviceClearance

Product code PLB— Cardiovascular

AITRICS-VC

Classification name
Multivariate Vital Signs Index
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Total cleared
8
First cleared
Most recent

FDA classification definition

“Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.”

— U.S. Food and Drug Administration, device classification record for product code PLB under 21 CFR 870.2300, via openFDA

Market context for product code PLB

FDA has cleared 8 devices under product code PLB between 1985 and 2024, filed by 7 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 PLB

Recent clearances under product code PLB

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