510(k) · Cleared
ClearedMasimo Stork
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Cleared on May 3, 2024 as substantially equivalent to DEN220091 (Owlet Babycare, Inc., 2023) after a 135-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- May 3, 2024
- Review
- 135 days
- Class
- Class II
- Product code
- QYU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220091 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220091 Dream SockOwlet Babycare, Inc. · 2023
- This deviceK234021 Masimo StorkMasimo Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220091 | Dream Sock | Owlet Babycare, Inc. | 2023 | — |
| 0 (this device) | K234021 | Masimo Stork | Masimo Corporation | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QYU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN220091 | Dream SockSummary page 4…tration 3011353843 Number: Reason for Premarket Introduction of Masimo Stork for OTC use Notification: Predicate Device: DEN220091 – Dream Sock Reference Device: K223721 – Masimo Stork 1 Device Description This submission covers the… | 2023 |
| † | K223721 | Masimo Stork | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QYU devicesQYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QYU
1in 2024
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) during no-motion, motion, and low perfusion conditions of infants and neonates who are 0 to 18 months of age and between 6 to 30 lbs. The Masimo Stork™ is also indicated for continuous skin…
Read the full statement (204 words)
The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters.
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) during no-motion, motion, and low perfusion conditions of infants and neonates who are 0 to 18 months of age and between 6 to 30 lbs. The Masimo Stork™ is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months and between 6 to 30 lbs. Masimo Stork™ is indicated for use in home environments.
The Masimo Stork can be used to supplement a caregiver's decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2; rather, the Masimo Stork™ is intended to provide a notification only when sufficient data are available for analysis.
The Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. The Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234021: Masimo Stork.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026