FDA product code DXL: Injector, Indicator
DXL is the FDA product code for injector, indicator. It is a Class II device, regulated under 21 CFR 870.1660 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under DXL, from 2 different applicants. The average 510(k) review took 19 days (median 11).
Classification
| Field | Value |
|---|---|
| Device name | Injector, Indicator |
| Device class | Class II |
| Regulation | 21 CFR 870.1660 |
| 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 DXL clearance
Top DXL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 2 | 1976-08-27 |
| Unimetrics Corp. | 1 | 1976-09-03 |
Most recent DXL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760500 | Unimetrics Corp. | TUBE, HEAVY GLASS WALL INJECTION | 1976-09-03 | 11 |
| K760448 | Instrumentation Laboratory CO | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT | 1976-08-27 | 11 |
| K760066 | Instrumentation Laboratory CO | TRAY, ICED INJECTABLE (26420) | 1976-07-21 | 35 |
Recalls for DXL devices
openFDA lists no recalls for product code DXL.
Frequently asked questions
What is FDA product code DXL?
DXL is the FDA product code for injector, indicator. It is a Class II device, regulated under 21 CFR 870.1660 and reviewed by the Cardiovascular panel.
What device class is DXL?
Class II, regulation 21 CFR 870.1660. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXL?
Across 3 cleared submissions the average was 19 days from receipt to decision (median 11).
Which companies have the most DXL clearances?
Instrumentation Laboratory CO (2); Unimetrics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DXL
- Run a recall and safety report across every DXL manufacturer
- Watch product code DXL 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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