FDA product code MLC: Monitor, St Segment
MLC is the FDA product code for monitor, st segment. It is a Class II device, regulated under 21 CFR 870.2340 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under MLC, from 2 different applicants. The average 510(k) review took 189 days (median 189).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, St Segment |
| Device class | Class II |
| Regulation | 21 CFR 870.2340 |
| 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 MLC clearance
Top MLC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Draeger Medical, Inc. | 1 | 2000-03-23 |
| Datascope Corp. | 1 | 1993-08-06 |
Most recent MLC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993826 | Draeger Medical, Inc. | NARKOMED 6000 | 2000-03-23 | 132 |
| K926099 | Datascope Corp. | DATASCOPE 6000 MONITOR | 1993-08-06 | 246 |
Recalls for MLC devices
openFDA lists no recalls for product code MLC.
Frequently asked questions
What is FDA product code MLC?
MLC is the FDA product code for monitor, st segment. It is a Class II device, regulated under 21 CFR 870.2340 and reviewed by the Cardiovascular panel.
What device class is MLC?
Class II, regulation 21 CFR 870.2340. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLC?
Across 2 cleared submissions the average was 189 days from receipt to decision (median 189).
Which companies have the most MLC clearances?
Draeger Medical, Inc. (1); Datascope Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MLC
- Run a recall and safety report across every MLC manufacturer
- Watch product code MLC 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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