FDA product code DXM: Densitometer
DXM is the FDA product code for densitometer. It is a Class II device, regulated under 21 CFR 870.1450 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under DXM, from 2 different applicants. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Densitometer |
| Device class | Class II |
| Regulation | 21 CFR 870.1450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DXM clearance
Top DXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instromedix, Inc. | 1 | 1979-11-05 |
| Waters Assoc., Inc. | 1 | 1978-11-29 |
Most recent DXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791892 | Instromedix, Inc. | TAPE-A-TRACE | 1979-11-05 | 41 |
| K781692 | Waters Assoc., Inc. | CALIBRATOR, DYNAMIC | 1978-11-29 | 56 |
Recalls for DXM devices
openFDA lists no recalls for product code DXM.
Frequently asked questions
What is FDA product code DXM?
DXM is the FDA product code for densitometer. It is a Class II device, regulated under 21 CFR 870.1450 and reviewed by the Cardiovascular panel.
What device class is DXM?
Class II, regulation 21 CFR 870.1450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXM?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most DXM clearances?
Instromedix, Inc. (1); Waters Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DXM
- Run a recall and safety report across every DXM manufacturer
- Watch product code DXM 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times