FDA 510(k) · Masimo
K234021: Masimo Stork (Masimo Corporation)
Masimo Corporation received FDA 510(k) K234021 for Masimo Stork, with a decision date of May 3, 2024 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (derived: product code name)
FDA facts
| FDA number | K234021 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Stork |
| Product code | QYU: Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2705 |
| Device class | Class 2 |
| Date received | Dec 20, 2023 |
| Decision date | May 3, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QYU is "Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use", class 2, 21 CFR 870.2705. FDA's 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)."
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Other. These are heuristics, not FDA fields.