FDA product code HJB: Instrument, Measuring, Corneal Radius
HJB is the FDA product code for instrument, measuring, corneal radius. It is a Class I device, regulated under 21 CFR 886.1450 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HJB, from 5 different applicants. The average 510(k) review took 111 days (median 96). FDA has posted 2 recalls for HJB devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Measuring, Corneal Radius |
| Device class | Class I |
| Regulation | 21 CFR 886.1450 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HJB clearance
Top HJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marco Ophthalmic, Inc. | 1 | 1993-08-09 |
| R.H. Burton Co. | 1 | 1993-04-05 |
| Heidelberg Instruments | 1 | 1986-12-15 |
| Kera Corp. | 1 | 1986-11-13 |
| Acufex Microsurgical, Inc. | 1 | 1985-09-11 |
Most recent HJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930444 | Marco Ophthalmic, Inc. | MARCO STANDARD KERATOMETERS | 1993-08-09 | 195 |
| K924779 | R.H. Burton Co. | BURTON KERATOMETER - MODLE 2040 | 1993-04-05 | 194 |
| K864369 | Heidelberg Instruments | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | 1986-12-15 | 40 |
| K864037 | Kera Corp. | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | 1986-11-13 | 28 |
| K852424 | Acufex Microsurgical, Inc. | ACUFEX COMPARATIVE SURGICAL KERATOMETER | 1985-09-11 | 96 |
Recalls for HJB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-11-14.
Frequently asked questions
What is FDA product code HJB?
HJB is the FDA product code for instrument, measuring, corneal radius. It is a Class I device, regulated under 21 CFR 886.1450 and reviewed by the Ophthalmic panel.
What device class is HJB?
Class I, regulation 21 CFR 886.1450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJB?
Across 5 cleared submissions the average was 111 days from receipt to decision (median 96).
Which companies have the most HJB clearances?
Marco Ophthalmic, Inc. (1); R.H. Burton Co. (1); Heidelberg Instruments (1); Kera Corp. (1); Acufex Microsurgical, Inc. (1).
Have HJB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2011-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code HJB
- Run a recall and safety report across every HJB manufacturer
- Watch product code HJB 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