FDA product code DXR: Ballistocardiograph
DXR is the FDA product code for ballistocardiograph. It is a Class II device, regulated under 21 CFR 870.2320 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under DXR, 1 in the last five years, from 5 different applicants. The average 510(k) review took 251 days (median 246); 246 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Ballistocardiograph |
| Device class | Class II |
| Regulation | 21 CFR 870.2320 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 246 |
Compare with all 510(k) review times · Search every DXR clearance
Top DXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiosense, Inc. | 1 | 2025-07-22 |
| Corsens Medical , Ltd. | 1 | 2016-11-21 |
| Heartforce Medical, Inc. | 1 | 2009-07-24 |
| Vital Science Corp. | 1 | 1987-08-11 |
| Frantz Medical Development, Ltd. | 1 | 1987-02-06 |
Most recent DXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243566 | Cardiosense, Inc. | CardioTag | 2025-07-22 | 246 |
| K160656 | Corsens Medical , Ltd. | CorSens | 2016-11-21 | 258 |
| K081603 | Heartforce Medical, Inc. | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | 2009-07-24 | 413 |
| K870442 | Vital Science Corp. | QUANTASCOPE | 1987-08-11 | 189 |
| K863508 | Frantz Medical Development, Ltd. | FRANTZ MEDICAL ELECTRODE | 1987-02-06 | 150 |
Recalls for DXR devices
openFDA lists no recalls for product code DXR.
Frequently asked questions
What is FDA product code DXR?
DXR is the FDA product code for ballistocardiograph. It is a Class II device, regulated under 21 CFR 870.2320 and reviewed by the Cardiovascular panel.
What device class is DXR?
Class II, regulation 21 CFR 870.2320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXR?
Across 5 cleared submissions the average was 251 days from receipt to decision (median 246).
Which companies have the most DXR clearances?
Cardiosense, Inc. (1); Corsens Medical , Ltd. (1); Heartforce Medical, Inc. (1); Vital Science Corp. (1); Frantz Medical Development, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DXR
- Run a recall and safety report across every DXR manufacturer
- Watch product code DXR 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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