FDA product code HOW: Drum, Opticokinetic
HOW is the FDA product code for drum, opticokinetic. It is a Class I device, regulated under 21 CFR 886.1200 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HOW. The average 510(k) review took 31 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Drum, Opticokinetic |
| Device class | Class I |
| Regulation | 21 CFR 886.1200 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HOW clearance
Top HOW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life-Tech Intl., Inc. | 1 | 1982-11-01 |
Most recent HOW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822917 | Life-Tech Intl., Inc. | MODEL 5400 OPTOKINETIC STIMULATOR | 1982-11-01 | 31 |
Recalls for HOW devices
openFDA lists no recalls for product code HOW.
Frequently asked questions
What is FDA product code HOW?
HOW is the FDA product code for drum, opticokinetic. It is a Class I device, regulated under 21 CFR 886.1200 and reviewed by the Ophthalmic panel.
What device class is HOW?
Class I, regulation 21 CFR 886.1200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOW?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most HOW clearances?
Life-Tech Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOW
- Run a recall and safety report across every HOW manufacturer
- Watch product code HOW 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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