Masimo Stork
FDA 510(k) K234021 · Masimo Corporation
510(k) numberK234021
Submission
- Device name
- Masimo Stork
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- December 20, 2023
- Decision date
- May 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYU – Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2705
- Specialty
- Cardiovascular
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).
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| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
| K232512 | Masimo W1DPS · Traditional | 11/17/2023SE |
Questions and answers
When was Masimo Stork cleared by the FDA?
Masimo Stork (K234021) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 135 days after the submission was received.
What is the product code of K234021?
The FDA product code is QYU – Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2705.