HPNClass I
Magnet, Permanent
21 CFR 886.4445 / Ophthalmic
HPN is the FDA product code for Magnet, Permanent, a class I device type, regulated under 21 CFR 886.4445. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HPN
- Device name
- Magnet, Permanent
- Regulation
- 21 CFR 886.4445
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code HPN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 1 |
Applicants with the most clearances
Product code HPN| Applicant | Clearances |
|---|---|
| Ameritek, Inc. | 1 |
| Emory University School of Medicine | 1 |
| King Tool, Inc. | 1 |
| Miami Eye Technology, Inc. | 1 |
| Richard James, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.