QYUClass II
Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use
Cardiovascular · 21 CFR 870.2705
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).
MDR events10All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances2All time
Recent MDR events
10 adverse event reports on file
- OWLET BABY CAREMar 17, 2026DeathOwlet Baby Care, Inc3012977166-2026-00005
- OWLET DREAM SOCKMar 16, 2026MalfunctionOwlet Baby CareMW5185300
- OWLET DREAM SOCKMar 16, 2026MalfunctionOwlet Baby CareMW5185301
- OWLET BABY CAREFeb 20, 2026InjuryOwlet Baby Care, Inc.3012977166-2026-00004
- OWLET DREAM SOCKDec 30, 2025MalfunctionOwlet Baby Care, Inc.MW5181464
- OWLET BABY CARENov 11, 2025DeathOwlet Baby Care, Inc3012977166-2025-00003
- OWLET DREAM SOCKNov 7, 2025InjuryOwlet Baby CareMW5178670
- OWLET BABY CAREOct 20, 2025InjuryOwlet Baby Care, Inc.3012977166-2025-00002
- OWLET BABY CAREApr 18, 2025DeathOwlet Baby Care, Inc.3012977166-2025-00001
- OWLET DREAM SOCKDec 18, 2024InjuryOwlet Baby Care, Inc.MW5163762
Event type breakdown
Injury4
Death3
Malfunction3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
2 clearances for this product code