FDA product code HLH: Pupillometer, Manual
HLH is the FDA product code for pupillometer, manual. It is a Class I device, regulated under 21 CFR 886.1700 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HLH. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Pupillometer, Manual |
| Device class | Class I |
| Regulation | 21 CFR 886.1700 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HLH clearance
Top HLH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Equipment Designs, Inc. | 2 | 1982-06-14 |
Most recent HLH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821082 | Medical Equipment Designs, Inc. | TRIAL LENS SET | 1982-06-14 | 56 |
| K821083 | Medical Equipment Designs, Inc. | P.D. METER | 1982-06-14 | 56 |
Recalls for HLH devices
openFDA lists no recalls for product code HLH.
Frequently asked questions
What is FDA product code HLH?
HLH is the FDA product code for pupillometer, manual. It is a Class I device, regulated under 21 CFR 886.1700 and reviewed by the Ophthalmic panel.
What device class is HLH?
Class I, regulation 21 CFR 886.1700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLH?
Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most HLH clearances?
Medical Equipment Designs, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HLH
- Run a recall and safety report across every HLH manufacturer
- Watch product code HLH 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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