Loss Of Pulse Notification Software
Loss of pulse notification software is an over-the-counter cardiovascular software device that analyzes photoplethysmograph (PPG) data to provide information for identifying loss of pulse, intended to alert users or caregivers to a potentially life-threatening cardiovascular event without providing a formal diagnosis. It is classified as FDA Class II (510(k) required) under regulation 870.2790 in the Cardiovascular specialty, with product code SDY. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SDY
- Device Class
- FDA class 2
- Regulation Number
- 870.2790
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242967 | Loss of Pulse Detection | Feb 25, 2025 | Substantially Equivalent | Fitbit |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.