FDA product code QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use
QDB is the FDA product code for photoplethysmograph analysis software for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2790 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under QDB, 3 in the last five years, from 2 different applicants. The average 510(k) review took 144 days (median 126). 1 De Novo request was granted under it.
Definition
A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Photoplethysmograph Analysis Software For Over-The-Counter Use |
| 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 QDB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 73 |
| 2022 | 2 | 208 |
| 2023 | 1 | 87 |
Compare with all 510(k) review times · Search every QDB clearance
Top QDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apple, Inc. | 3 | 2023-07-21 |
| Fitbit, Inc. | 1 | 2022-04-08 |
Most recent QDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231173 | Apple, Inc. | Irregular Rhythm Notification Feature (IRNF) | 2023-07-21 | 87 |
| K213971 | Apple, Inc. | Atrial Fibrillation History Feature | 2022-06-03 | 165 |
| K212372 | Fitbit, Inc. | Fitbit Irregular Rhythm Notifications | 2022-04-08 | 252 |
| K212516 | Apple, Inc. | IRNF App | 2021-10-22 | 73 |
Recalls for QDB devices
openFDA lists no recalls for product code QDB.
Frequently asked questions
What is FDA product code QDB?
QDB is the FDA product code for photoplethysmograph analysis software for over-the-counter use. It is a Class II device, regulated under 21 CFR 870.2790 and reviewed by the Cardiovascular panel.
What device class is QDB?
Class II, regulation 21 CFR 870.2790. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDB?
Across 4 cleared submissions the average was 144 days from receipt to decision (median 126).
Which companies have the most QDB clearances?
Apple, Inc. (3); Fitbit, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDB
- Run a recall and safety report across every QDB manufacturer
- Watch product code QDB 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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