FDA product code EPN: Pump, Nebulizer, Manual
EPN is the FDA product code for pump, nebulizer, manual. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under EPN, from 2 different applicants. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Pump, Nebulizer, Manual |
| 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 EPN clearance
Top EPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Devilbiss Health Care, Inc. | 1 | 1989-11-30 |
| Dhd Medical Products Div. Diemolding Corp. | 1 | 1980-10-23 |
Most recent EPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896090 | Devilbiss Health Care, Inc. | DEVILBISS MODEL 6300D | 1989-11-30 | 42 |
| K802430 | Dhd Medical Products Div. Diemolding Corp. | NEBULIZER, MEDICINAL | 1980-10-23 | 17 |
Recalls for EPN devices
openFDA lists no recalls for product code EPN.
Frequently asked questions
What is FDA product code EPN?
EPN is the FDA product code for pump, nebulizer, manual. 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 EPN?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EPN?
Across 2 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most EPN clearances?
Devilbiss Health Care, Inc. (1); Dhd Medical Products Div. Diemolding Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EPN
- Run a recall and safety report across every EPN manufacturer
- Watch product code EPN 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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