FDA product code HJH: Loupe, Binocular, Low Power
HJH is the FDA product code for loupe, binocular, low power. It is a Class I device, regulated under 21 CFR 886.5120 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HJH, from 3 different applicants. The average 510(k) review took 25 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Loupe, Binocular, Low Power |
| Device class | Class I |
| Regulation | 21 CFR 886.5120 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top HJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Valley Forge Scientific Corp. | 1 | 1987-12-23 |
| Exeter Instruments, Inc. | 1 | 1986-11-10 |
| Almore Intl., Inc. | 1 | 1983-04-06 |
Most recent HJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874845 | Valley Forge Scientific Corp. | MALIS SURGICAL LOUPES | 1987-12-23 | 29 |
| K863983 | Exeter Instruments, Inc. | EXETER OPERATING LOUPE | 1986-11-10 | 27 |
| K830878 | Almore Intl., Inc. | BINOCULAR LOUPE | 1983-04-06 | 19 |
Recalls for HJH devices
openFDA lists no recalls for product code HJH.
Frequently asked questions
What is FDA product code HJH?
HJH is the FDA product code for loupe, binocular, low power. It is a Class I device, regulated under 21 CFR 886.5120 and reviewed by the Ophthalmic panel.
What device class is HJH?
Class I, regulation 21 CFR 886.5120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJH?
Across 3 cleared submissions the average was 25 days from receipt to decision (median 27).
Which companies have the most HJH clearances?
Valley Forge Scientific Corp. (1); Exeter Instruments, Inc. (1); Almore Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJH
- Run a recall and safety report across every HJH manufacturer
- Watch product code HJH 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.