FDA product code HPN: Magnet, Permanent
HPN is the FDA product code for magnet, permanent. It is a Class I device, regulated under 21 CFR 886.4445 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HPN, from 5 different applicants. The average 510(k) review took 53 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Magnet, Permanent |
| Device class | Class I |
| Regulation | 21 CFR 886.4445 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HPN clearance
Top HPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| King Tool, Inc. | 1 | 1991-02-14 |
| Emory University School of Medicine | 1 | 1990-02-09 |
| Richard James, Inc. | 1 | 1988-04-01 |
| Ameritek, Inc. | 1 | 1986-03-31 |
| Miami Eye Technology, Inc. | 1 | 1983-06-30 |
Most recent HPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905237 | King Tool, Inc. | EYE SEE INSTRUMENT | 1991-02-14 | 90 |
| K896473 | Emory University School of Medicine | H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR | 1990-02-09 | 88 |
| K880855 | Richard James, Inc. | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG | 1988-04-01 | 31 |
| K860960 | Ameritek, Inc. | RARE EARTH INTRA-OCULAR MAGNET | 1986-03-31 | 18 |
| K831702 | Miami Eye Technology, Inc. | RARE-EARTH INTRA-OCULAR MAGNET | 1983-06-30 | 36 |
Recalls for HPN devices
openFDA lists no recalls for product code HPN.
Frequently asked questions
What is FDA product code HPN?
HPN is the FDA product code for magnet, permanent. It is a Class I device, regulated under 21 CFR 886.4445 and reviewed by the Ophthalmic panel.
What device class is HPN?
Class I, regulation 21 CFR 886.4445. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPN?
Across 5 cleared submissions the average was 53 days from receipt to decision (median 36).
Which companies have the most HPN clearances?
King Tool, Inc. (1); Emory University School of Medicine (1); Richard James, Inc. (1); Ameritek, Inc. (1); Miami Eye Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPN
- Run a recall and safety report across every HPN manufacturer
- Watch product code HPN 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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