FDA product code HJC: Esthesiometer, Ocular
HJC is the FDA product code for esthesiometer, ocular. It is a Class I device, regulated under 21 CFR 886.1040 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HJC, from 2 different applicants. The average 510(k) review took 67 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Esthesiometer, Ocular |
| Device class | Class I |
| Regulation | 21 CFR 886.1040 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HJC clearance
Top HJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Connecticut Bioinstruments, Inc. | 1 | 1992-04-21 |
| Luneau SA | 1 | 1985-05-30 |
Most recent HJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920271 | Connecticut Bioinstruments, Inc. | WEINSTEIN CORNEAL MIRCOAESTHESIOMETER | 1992-04-21 | 90 |
| K851557 | Luneau SA | ANESTHESIOMETER | 1985-05-30 | 44 |
Recalls for HJC devices
openFDA lists no recalls for product code HJC.
Frequently asked questions
What is FDA product code HJC?
HJC is the FDA product code for esthesiometer, ocular. It is a Class I device, regulated under 21 CFR 886.1040 and reviewed by the Ophthalmic panel.
What device class is HJC?
Class I, regulation 21 CFR 886.1040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJC?
Across 2 cleared submissions the average was 67 days from receipt to decision (median 67).
Which companies have the most HJC clearances?
Connecticut Bioinstruments, Inc. (1); Luneau SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJC
- Run a recall and safety report across every HJC manufacturer
- Watch product code HJC 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