FDA product code LQW: Test, Temperature Discrimination
LQW is the FDA product code for test, temperature discrimination. It is a Class I device, regulated under 21 CFR 882.1200 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under LQW, from 3 different applicants. The average 510(k) review took 232 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Test, Temperature Discrimination |
| Device class | Class I |
| Regulation | 21 CFR 882.1200 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LQW clearance
Top LQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prosenex | 1 | 2014-07-23 |
| Medoc Corp. | 1 | 1993-10-21 |
| Sensortek, Inc. | 1 | 1987-01-29 |
Most recent LQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141208 | Prosenex | DYNAMIC NEUROSCREENING DEVICE | 2014-07-23 | 75 |
| K922052 | Medoc Corp. | TSA 2001 THERMAL SENSORY ANALYZER | 1993-10-21 | 535 |
| K864345 | Sensortek, Inc. | NTE-2 THERMAL SENSITIVITY TESTER | 1987-01-29 | 86 |
Recalls for LQW devices
openFDA lists no recalls for product code LQW.
Frequently asked questions
What is FDA product code LQW?
LQW is the FDA product code for test, temperature discrimination. It is a Class I device, regulated under 21 CFR 882.1200 and reviewed by the Neurology panel.
What device class is LQW?
Class I, regulation 21 CFR 882.1200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQW?
Across 3 cleared submissions the average was 232 days from receipt to decision (median 86).
Which companies have the most LQW clearances?
Prosenex (1); Medoc Corp. (1); Sensortek, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQW
- Run a recall and safety report across every LQW manufacturer
- Watch product code LQW 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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