FDA product code HMH: Rack, Skiascopic
HMH is the FDA product code for rack, skiascopic. It is a Class I device, regulated under 21 CFR 886.1750 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HMH, from 2 different applicants. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Rack, Skiascopic |
| Device class | Class I |
| Regulation | 21 CFR 886.1750 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Top HMH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luneau Laboratories | 1 | 1985-01-02 |
| Visitec Co. | 1 | 1984-10-05 |
Most recent HMH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844364 | Luneau Laboratories | SKIASCOPIC RACKS | 1985-01-02 | 50 |
| K843195 | Visitec Co. | VISITEC FLIERINGA-LEGRAND FIXATION RING | 1984-10-05 | 52 |
Recalls for HMH devices
openFDA lists no recalls for product code HMH.
Frequently asked questions
What is FDA product code HMH?
HMH is the FDA product code for rack, skiascopic. It is a Class I device, regulated under 21 CFR 886.1750 and reviewed by the Ophthalmic panel.
What device class is HMH?
Class I, regulation 21 CFR 886.1750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMH?
Across 2 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most HMH clearances?
Luneau Laboratories (1); Visitec Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMH
- Run a recall and safety report across every HMH manufacturer
- Watch product code HMH 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.