DeviceClearance

Product code SDY— Cardiovascular

Loss of Pulse Detection

Classification name
Loss Of Pulse Notification Software
Device class
Class 2
Regulation
21 CFR 870.2790
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis.”

— U.S. Food and Drug Administration, device classification record for product code SDY under 21 CFR 870.2790, via openFDA

Market context for product code SDY

FDA has cleared 1 device under product code SDY, all in 2025, 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 SDY

Recent clearances under product code SDY

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