FDA product code JPW: Pump, Nebulizer, Electrically Powered
JPW is the FDA product code for pump, nebulizer, electrically powered. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under JPW. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Pump, Nebulizer, Electrically Powered |
| Device class | Class I |
| Regulation | 21 CFR 874.5220 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JPW clearance
Top JPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Buckman Co., Inc. | 1 | 1983-12-27 |
Most recent JPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833866 | Buckman Co., Inc. | ACE/KYLE SELF TAPPING CANNULATED TITA | 1983-12-27 | 50 |
Recalls for JPW devices
openFDA lists no recalls for product code JPW.
Frequently asked questions
What is FDA product code JPW?
JPW is the FDA product code for pump, nebulizer, electrically powered. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.
What device class is JPW?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JPW?
Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most JPW clearances?
Buckman Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JPW
- Run a recall and safety report across every JPW manufacturer
- Watch product code JPW 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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