FDA product code POP: Cranial Motion Measurement Device
POP is the FDA product code for cranial motion measurement device. It is a Class II device, regulated under 21 CFR 882.1630 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under POP. The average 510(k) review took 30 days (median 30). 1 De Novo request was granted under it.
Definition
A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Motion Measurement Device |
| Device class | Class II |
| Regulation | 21 CFR 882.1630 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for POP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 30 |
Compare with all 510(k) review times · Search every POP clearance
Top POP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jan Medical, Inc. | 1 | 2017-04-28 |
Most recent POP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170926 | Jan Medical, Inc. | BrainPulse 1100 | 2017-04-28 | 30 |
Recalls for POP devices
openFDA lists no recalls for product code POP.
Frequently asked questions
What is FDA product code POP?
POP is the FDA product code for cranial motion measurement device. It is a Class II device, regulated under 21 CFR 882.1630 and reviewed by the Neurology panel.
What device class is POP?
Class II, regulation 21 CFR 882.1630. Typical premarket route: 510(k).
How long does a 510(k) take for product code POP?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most POP clearances?
Jan Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code POP
- Run a recall and safety report across every POP manufacturer
- Watch product code POP 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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