DeviceClearance

Product code QYU— Cardiovascular

Dream Sock

Classification name
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Device class
Class 2
Regulation
21 CFR 870.2705
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).”

— U.S. Food and Drug Administration, device classification record for product code QYU under 21 CFR 870.2705, via openFDA

Market context for product code QYU

FDA has cleared 2 devices under product code QYU between 2023 and 2024, filed by 2 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 QYU

Adverse events under product code QYU

product code QYU
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QYU

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