FDA product code · Cardiovascular

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

Name: FDA decisions, review times, recalls and adverse event reports for product code QYU
Creator: 510(k) Report

QYUClass II21 CFR 870.2705510(k) required2 decisions since 20230 recalls

2 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 135 days (half between 135 and 135). No recall names this code. The most-cited predicate is DEN220091, named by 1 later device.

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).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of QYU at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QYU

1in 2024

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QYU

Too few QYU 510(k)s in any year since 2007 to give a median.

Recalls per year · QYU

No recall names QYU since 2007.

Adverse event reports per year · QYU

5in 2025

2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QYU, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	1	—	1
2025	0	—	5
2026	0	—	—

FIG. 1 — QYU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QYU? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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

Which predicates do QYU devices cite most?

Which QYU devices have the deepest lineage?

What has FDA decided in QYU lately?