FDA product code HMF: Stand, Instrument, Ac-Powered, Ophthalmic
HMF is the FDA product code for stand, instrument, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel. FDA has cleared 15 510(k) submissions under HMF, from 11 different applicants. The average 510(k) review took 94 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Stand, Instrument, Ac-Powered, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1860 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HMF clearance
Top HMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rota Systems Medfurniture, Inc. | 2 | 1994-04-19 |
| R.H. Burton Co. | 2 | 1993-04-05 |
| Luneau Laboratories | 2 | 1984-12-11 |
| Bausch & Lomb, Inc. | 2 | 1979-07-24 |
| Rota Systems,Inc. | 1 | 1994-04-19 |
6 more applicants have HMF clearances. See the full list in Caduvo.
Most recent HMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935945 | Rota Systems,Inc. | ROTA DATAMATE I | 1994-04-19 | 127 |
| K935952 | Rota Systems Medfurniture, Inc. | ROTA SYSTEM 5000 | 1994-04-19 | 127 |
| K931839 | Rota Systems Medfurniture, Inc. | ROTA SYSTEM XL | 1993-11-22 | 223 |
| K930440 | Marco Ophthalmic, Inc. | MARCO INTERNATIONAL STAND | 1993-07-06 | 161 |
| K924771 | R.H. Burton Co. | BURTON OPHTHALMIC STAND - MODEL XL3200 | 1993-04-05 | 194 |
Recalls for HMF devices
openFDA lists no recalls for product code HMF.
Frequently asked questions
What is FDA product code HMF?
HMF is the FDA product code for stand, instrument, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel.
What device class is HMF?
Class I, regulation 21 CFR 886.1860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMF?
Across 15 cleared submissions the average was 94 days from receipt to decision (median 53).
Which companies have the most HMF clearances?
Rota Systems Medfurniture, Inc. (2); R.H. Burton Co. (2); Luneau Laboratories (2); Bausch & Lomb, Inc. (2); Rota Systems,Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMF
- Run a recall and safety report across every HMF manufacturer
- Watch product code HMF 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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