FDA product code HJA: Photokeratoscope
HJA is the FDA product code for photokeratoscope. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HJA, from 5 different applicants. The average 510(k) review took 64 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Photokeratoscope |
| Device class | Class I |
| Regulation | 21 CFR 886.1350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HJA clearance
Top HJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Sanborn Co. | 1 | 1990-06-27 |
| Technitex, Inc. | 1 | 1989-09-11 |
| American Medical Optics | 1 | 1984-08-07 |
| Jedmed Instrument Co. | 1 | 1983-03-09 |
| Clifford M. Terry, M.C. | 1 | 1978-10-17 |
Most recent HJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901523 | The Sanborn Co. | VKG 1000, VIDEO KERATOGRAPH | 1990-06-27 | 86 |
| K893968 | Technitex, Inc. | VKG 2000 VIDEO KERATOMETER | 1989-09-11 | 101 |
| K842128 | American Medical Optics | AMERICAN MEDICAL OPTICS PHOTOKERATO | 1984-08-07 | 70 |
| K830290 | Jedmed Instrument Co. | DORC CONTACT/PHOTO DERATOSCOPE | 1983-03-09 | 41 |
| K781650 | Clifford M. Terry, M.C. | TERRY KERATOMETER | 1978-10-17 | 20 |
Recalls for HJA devices
openFDA lists no recalls for product code HJA.
Frequently asked questions
What is FDA product code HJA?
HJA is the FDA product code for photokeratoscope. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel.
What device class is HJA?
Class I, regulation 21 CFR 886.1350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJA?
Across 5 cleared submissions the average was 64 days from receipt to decision (median 70).
Which companies have the most HJA clearances?
The Sanborn Co. (1); Technitex, Inc. (1); American Medical Optics (1); Jedmed Instrument Co. (1); Clifford M. Terry, M.C. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJA
- Run a recall and safety report across every HJA manufacturer
- Watch product code HJA 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times