FDA product code HJI: Lens, Fundus, Hruby, Diagnostic
HJI is the FDA product code for lens, fundus, hruby, diagnostic. It is a Class I device, regulated under 21 CFR 886.1395 and reviewed by the Ophthalmic panel. FDA has cleared 8 510(k) submissions under HJI, from 7 different applicants. The average 510(k) review took 62 days (median 73). FDA has posted 1 recall for HJI devices.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Fundus, Hruby, Diagnostic |
| Device class | Class I |
| Regulation | 21 CFR 886.1395 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HJI clearance
Top HJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper Medical Devices Corp. | 2 | 1981-02-05 |
| Ocular Instruments, Inc. | 1 | 1992-11-16 |
| Canon USA, Inc. | 1 | 1990-07-05 |
| Academic Catalyst Corp. | 1 | 1990-07-05 |
| Innovision Medical, Inc. | 1 | 1990-03-12 |
2 more applicants have HJI clearances. See the full list in Caduvo.
Most recent HJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923670 | Ocular Instruments, Inc. | BYRNE EXPULSIVE LENS | 1992-11-16 | 117 |
| K902138 | Academic Catalyst Corp. | STRIPE PROJECTOR | 1990-07-05 | 56 |
| K901839 | Canon USA, Inc. | 60 FUNDUS CAMERA CF-60UV | 1990-07-05 | 72 |
| K897186 | Innovision Medical, Inc. | LASER IMAGING WORK STATION | 1990-03-12 | 74 |
| K820223 | Optical Micro Systems, Inc. | OMS QUARTZ INFUSION CONTACT LENS | 1982-02-05 | 9 |
Recalls for HJI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-27.
Frequently asked questions
What is FDA product code HJI?
HJI is the FDA product code for lens, fundus, hruby, diagnostic. It is a Class I device, regulated under 21 CFR 886.1395 and reviewed by the Ophthalmic panel.
What device class is HJI?
Class I, regulation 21 CFR 886.1395. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJI?
Across 8 cleared submissions the average was 62 days from receipt to decision (median 73).
Which companies have the most HJI clearances?
Cooper Medical Devices Corp. (2); Ocular Instruments, Inc. (1); Canon USA, Inc. (1); Academic Catalyst Corp. (1); Innovision Medical, Inc. (1).
Have HJI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HJI
- Run a recall and safety report across every HJI manufacturer
- Watch product code HJI 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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