DXR
5 FDA 510(k) clearances · Product code
246 daysmedian time to decision
413 days90th percentile
5clearances measured
FDA profile
- Official device name
- Ballistocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2320
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CardioTag™ (K243566) | Cardiosense, Inc. | 2025-07-22 |
| CorSens (K160656) | Corsens Medical , Ltd. | 2016-11-21 |
| DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) | Heartforce Medical, Inc. | 2009-07-24 |
| QUANTASCOPE (K870442) | Vital Science Corp. | 1987-08-11 |
| FRANTZ MEDICAL ELECTRODE (K863508) | Frantz Medical Development, Ltd. | 1987-02-06 |
Track DXR automatically
Every clearance here is in the API, with alerts when new ones post.