DeviceClearance

Product code SAR— Cardiovascular

APPRAISE-HRI

Classification name
Adjunctive Hemodynamic Indicator With Decision Point For Military Use
Device class
Class 2
Regulation
21 CFR 870.2220
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military.”

— U.S. Food and Drug Administration, device classification record for product code SAR under 21 CFR 870.2220, via openFDA

Market context for product code SAR

FDA has cleared 1 device under product code SAR, all in 2024, 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 SAR

Recent clearances under product code SAR

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