510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220091Unknown

Dream Sock

Owlet Babycare, Inc., Lehi UT / Direct, Unknown
FDA source (opens on fda.gov)

DEN220091 is the FDA 510(k) clearance record for Dream Sock, a class II device, cleared for Owlet Babycare, Inc. on under FDA product code QYU (Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use). FDA's definition for product code QYU reads: "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...". FDA records list 2 510(k) clearances for Owlet Babycare, Inc., from to . As of , FDA records show no recalls naming DEN220091.

Clearance record

Decision date
Received
(329 days to decision)
Product code
QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Regulation
21 CFR 870.2705
Device class
Class II
Review panel
Cardiovascular
Applicant
Owlet Babycare, Inc. 3300 N. Ashton Blvd., Suite 300, Lehi UT
Third party review
No

Clearances, product code QYU

Trailing 12 months

FDA records hold no clearances under product code QYU in the trailing twelve months.

FDA records show no clearances under product code QYU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260