FDA product code HMG: Stand, Instrument, Ophthalmic, Non-Powered
HMG is the FDA product code for stand, instrument, ophthalmic, non-powered. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HMG, from 4 different applicants. The average 510(k) review took 37 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Stand, Instrument, Ophthalmic, Non-Powered |
| 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 HMG clearance
Top HMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 1 | 1990-02-16 |
| Site Microsurgical Systems, Inc. | 1 | 1988-09-12 |
| Gorsk, Inc. | 1 | 1987-10-23 |
| Woodlyn, Inc. | 1 | 1984-06-01 |
Most recent HMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900161 | Jedmed Instrument Co. | A-SCAN ROLL-AROUND STAND | 1990-02-16 | 35 |
| K883575 | Site Microsurgical Systems, Inc. | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE | 1988-09-12 | 21 |
| K873554 | Gorsk, Inc. | GORSK INSTRUMENT REST | 1987-10-23 | 56 |
| K841759 | Woodlyn, Inc. | OPHTHALMIC TABLE | 1984-06-01 | 35 |
Recalls for HMG devices
openFDA lists no recalls for product code HMG.
Frequently asked questions
What is FDA product code HMG?
HMG is the FDA product code for stand, instrument, ophthalmic, non-powered. It is a Class I device, regulated under 21 CFR 886.1860 and reviewed by the Ophthalmic panel.
What device class is HMG?
Class I, regulation 21 CFR 886.1860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMG?
Across 4 cleared submissions the average was 37 days from receipt to decision (median 35).
Which companies have the most HMG clearances?
Jedmed Instrument Co. (1); Site Microsurgical Systems, Inc. (1); Gorsk, Inc. (1); Woodlyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMG
- Run a recall and safety report across every HMG manufacturer
- Watch product code HMG 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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