FDA product code HPO: Magnet, Ac-Powered
HPO is the FDA product code for magnet, ac-powered. It is a Class II device, regulated under 21 CFR 886.4440 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HPO, from 3 different applicants. The average 510(k) review took 54 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Magnet, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4440 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPO clearance
Top HPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mira, Inc. | 1 | 1986-02-19 |
| Scientific Manufacturer | 1 | 1983-10-19 |
| Jedmed Instrument Co. | 1 | 1983-03-09 |
Most recent HPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854870 | Mira, Inc. | INTRAOCULAR ELECTROMAGNET | 1986-02-19 | 77 |
| K832950 | Scientific Manufacturer | SCIENTRONICS 10K EYE MAGNET | 1983-10-19 | 49 |
| K830336 | Jedmed Instrument Co. | DORC INTRAOCULAR ELECTROMAGNET | 1983-03-09 | 36 |
Recalls for HPO devices
openFDA lists no recalls for product code HPO.
Frequently asked questions
What is FDA product code HPO?
HPO is the FDA product code for magnet, ac-powered. It is a Class II device, regulated under 21 CFR 886.4440 and reviewed by the Ophthalmic panel.
What device class is HPO?
Class II, regulation 21 CFR 886.4440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPO?
Across 3 cleared submissions the average was 54 days from receipt to decision (median 49).
Which companies have the most HPO clearances?
Mira, Inc. (1); Scientific Manufacturer (1); Jedmed Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPO
- Run a recall and safety report across every HPO manufacturer
- Watch product code HPO 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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