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

Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

21 CFR 870.2705 / Cardiovascular
FDA source (opens on fda.gov)

QYU is the FDA product code for Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use, a class II device type, regulated under 21 CFR 870.2705. FDA's definition for this code 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 vital sign(s) go outside preset threshold(s)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QYU
Device name
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
FDA 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).
Regulation
21 CFR 870.2705
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QYU

By decision year
2 clearances under product code QYU with a decision year between 2023 and 2024, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYU by decision year
YearClearances
20231
20241

Applicants with the most clearances

Product code QYU
Applicants holding the most 510(k) clearances under product code QYU
ApplicantClearances
Masimo Corporation1
Owlet Babycare, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code