FDA product code SDY: Loss Of Pulse Notification Software
SDY is the FDA product code for loss of pulse notification software. It is a Class II device, regulated under 21 CFR 870.2790 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under SDY, 1 in the last five years. The average 510(k) review took 152 days (median 152); 152 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Loss Of Pulse Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 870.2790 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for SDY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 152 |
Compare with all 510(k) review times · Search every SDY clearance
Top SDY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fitbit | 1 | 2025-02-25 |
Most recent SDY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242967 | Fitbit | Loss of Pulse Detection | 2025-02-25 | 152 |
Recalls for SDY devices
openFDA lists no recalls for product code SDY.
Frequently asked questions
What is FDA product code SDY?
SDY is the FDA product code for loss of pulse notification software. It is a Class II device, regulated under 21 CFR 870.2790 and reviewed by the Cardiovascular panel.
What device class is SDY?
Class II, regulation 21 CFR 870.2790. Typical premarket route: 510(k).
How long does a 510(k) take for product code SDY?
Across 1 cleared submissions the average was 152 days from receipt to decision (median 152).
Which companies have the most SDY clearances?
Fitbit (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SDY
- Run a recall and safety report across every SDY manufacturer
- Watch product code SDY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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