FDA product code HRJ: Table, Instrument, Powered, Ophthalmic
HRJ is the FDA product code for table, instrument, powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4855 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HRJ, from 7 different applicants. The average 510(k) review took 82 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Table, Instrument, Powered, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4855 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRJ clearance
Top HRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marco Ophthalmic, Inc. | 1 | 1993-07-06 |
| R.H. Burton Co. | 1 | 1992-09-30 |
| Alcon Laboratories | 1 | 1991-07-25 |
| Techna Vision | 1 | 1985-10-17 |
| Dentsply Intl. | 1 | 1985-09-24 |
2 more applicants have HRJ clearances. See the full list in Caduvo.
Most recent HRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930447 | Marco Ophthalmic, Inc. | MARCO H AND TS-1 INSTRUMENT TABLES | 1993-07-06 | 161 |
| K922242 | R.H. Burton Co. | 910T MONTORIZED INSTRUMENT TABLE | 1992-09-30 | 140 |
| K912134 | Alcon Laboratories | TBD, LENS MEASURING DEVICE | 1991-07-25 | 72 |
| K853744 | Techna Vision | TECHNA VISION, INC.ELECTRIC TABLE | 1985-10-17 | 41 |
| K853359 | Dentsply Intl. | RELIANCE 1379 | 1985-09-24 | 43 |
Recalls for HRJ devices
openFDA lists no recalls for product code HRJ.
Frequently asked questions
What is FDA product code HRJ?
HRJ is the FDA product code for table, instrument, powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4855 and reviewed by the Ophthalmic panel.
What device class is HRJ?
Class I, regulation 21 CFR 886.4855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRJ?
Across 7 cleared submissions the average was 82 days from receipt to decision (median 63).
Which companies have the most HRJ clearances?
Marco Ophthalmic, Inc. (1); R.H. Burton Co. (1); Alcon Laboratories (1); Techna Vision (1); Dentsply Intl. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRJ
- Run a recall and safety report across every HRJ manufacturer
- Watch product code HRJ 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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