FDA product code HPE: Aid, Vision, Optical, Battery-Powered
HPE is the FDA product code for aid, vision, optical, battery-powered. It is a Class I device, regulated under 21 CFR 886.5915 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HPE. The average 510(k) review took 83 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Aid, Vision, Optical, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.5915 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HPE clearance
Top HPE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sevrain-Tech, Inc. | 1 | 1989-01-19 |
Most recent HPE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884540 | Sevrain-Tech, Inc. | ETV, ELECTRONIC VISION AID | 1989-01-19 | 83 |
Recalls for HPE devices
openFDA lists no recalls for product code HPE.
Frequently asked questions
What is FDA product code HPE?
HPE is the FDA product code for aid, vision, optical, battery-powered. It is a Class I device, regulated under 21 CFR 886.5915 and reviewed by the Ophthalmic panel.
What device class is HPE?
Class I, regulation 21 CFR 886.5915. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPE?
Across 1 cleared submissions the average was 83 days from receipt to decision (median 83).
Which companies have the most HPE clearances?
Sevrain-Tech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPE
- Run a recall and safety report across every HPE manufacturer
- Watch product code HPE 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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