FDA product code LME: Monitor, Blood-Flow, Cerebral, Thermal Diffusion
LME is the FDA product code for monitor, blood-flow, cerebral, thermal diffusion. It is a Class III device, reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under LME. The average 510(k) review took 25 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Blood-Flow, Cerebral, Thermal Diffusion |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LME clearance
Top LME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Flowtronics, Inc. | 1 | 1985-02-22 |
Most recent LME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850657 | Flowtronics, Inc. | THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR | 1985-02-22 | 25 |
Recalls for LME devices
openFDA lists no recalls for product code LME.
Frequently asked questions
What is FDA product code LME?
LME is the FDA product code for monitor, blood-flow, cerebral, thermal diffusion. It is a Class III device, reviewed by the Neurology panel.
What device class is LME?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LME?
Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most LME clearances?
Flowtronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LME
- Run a recall and safety report across every LME manufacturer
- Watch product code LME 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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