FDA product code HMM: Distometer
HMM is the FDA product code for distometer. It is a Class I device, regulated under 21 CFR 886.1190 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HMM, from 2 different applicants. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Distometer |
| Device class | Class I |
| Regulation | 21 CFR 886.1190 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HMM clearance
Top HMM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hagg-Streit Service, Inc. | 1 | 1988-07-01 |
| Allegheny Plastics, Inc. | 1 | 1987-09-21 |
Most recent HMM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882575 | Hagg-Streit Service, Inc. | DISTOMETER | 1988-07-01 | 9 |
| K873440 | Allegheny Plastics, Inc. | RULE, PUPILLARY | 1987-09-21 | 25 |
Recalls for HMM devices
openFDA lists no recalls for product code HMM.
Frequently asked questions
What is FDA product code HMM?
HMM is the FDA product code for distometer. It is a Class I device, regulated under 21 CFR 886.1190 and reviewed by the Ophthalmic panel.
What device class is HMM?
Class I, regulation 21 CFR 886.1190. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMM?
Across 2 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most HMM clearances?
Hagg-Streit Service, Inc. (1); Allegheny Plastics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMM
- Run a recall and safety report across every HMM manufacturer
- Watch product code HMM 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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