K242967 is an FDA 510(k) clearance for the Loss of Pulse Detection. This device is classified as a Loss Of Pulse Notification Software (Class II - Special Controls, product code SDY).
Submitted by Fitbit (San Francisco, US). The FDA issued a Cleared decision on February 25, 2025, 152 days after receiving the submission on September 26, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2790. A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Loss Of Pulse. This Device Is Not Intended To Provide A Diagnosis..
| 510(k) Number | K242967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2024 |
| Decision Date | February 25, 2025 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SDY - Loss Of Pulse Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2790 |
| Definition | A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Loss Of Pulse. This Device Is Not Intended To Provide A Diagnosis. |