FDA product code QDA: Electrocardiograph Software For Over-The-Counter Use
QDA is the FDA product code for electrocardiograph software for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2345 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under QDA, 5 in the last five years, from 6 different applicants. The average 510(k) review took 177 days (median 139); 218 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Electrocardiograph Software For Over-The-Counter Use |
| Device class | Class II |
| Regulation | 21 CFR 870.2345 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QDA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 3 | 124 |
| 2023 | 2 | 147 |
| 2024 | 1 | 122 |
| 2025 | 2 | 313 |
Compare with all 510(k) review times · Search every QDA clearance
Top QDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Samsung Electronics Co., Ltd. | 3 | 2024-08-02 |
| Withings | 1 | 2025-06-15 |
| Whoop., Inc. | 1 | 2025-04-04 |
| Garmin International, Inc. | 1 | 2023-01-12 |
| Apple, Inc. | 1 | 2020-10-08 |
1 more applicants have QDA clearances. See the full list in Caduvo.
Most recent QDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240795 | Withings | Withings ECG App | 2025-06-15 | 450 |
| K243236 | Whoop., Inc. | WHOOP ECG (electrocardiogram) Feature (1.0) | 2025-04-04 | 176 |
| K240909 | Samsung Electronics Co., Ltd. | Samsung ECG App v 1.3 (ECG) | 2024-08-02 | 122 |
| K230292 | Samsung Electronics Co., Ltd. | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | 2023-05-02 | 89 |
| K221774 | Garmin International, Inc. | Garmin ECG App | 2023-01-12 | 205 |
Recalls for QDA devices
openFDA lists no recalls for product code QDA.
Frequently asked questions
What is FDA product code QDA?
QDA is the FDA product code for electrocardiograph software for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2345 and reviewed by the Cardiovascular panel.
What device class is QDA?
Class II, regulation 21 CFR 870.2345. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDA?
Across 8 cleared submissions the average was 177 days from receipt to decision (median 139).
Which companies have the most QDA clearances?
Samsung Electronics Co., Ltd. (3); Withings (1); Whoop., Inc. (1); Garmin International, Inc. (1); Apple, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDA
- Run a recall and safety report across every QDA manufacturer
- Watch product code QDA 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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