K234021 is an FDA 510(k) clearance for the Masimo Stork. This device is classified as a Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use (Class II - Special Controls, product code QYU).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on May 3, 2024, 135 days after receiving the submission on December 20, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2705. 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)..
| 510(k) Number | K234021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2023 |
| Decision Date | May 03, 2024 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QYU — Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2705 |
| 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). |