FDA product code HOT: Aid, Vision Image Intensification
HOT is the FDA product code for aid, vision image intensification. It is a Class I device, regulated under 21 CFR 886.5910 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HOT, from 2 different applicants. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Aid, Vision Image Intensification |
| Device class | Class I |
| Regulation | 21 CFR 886.5910 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HOT clearance
Top HOT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Swank Plus , Ltd. | 1 | 1988-02-26 |
| Sensory Aids Corp. | 1 | 1986-10-31 |
Most recent HOT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873967 | Swank Plus , Ltd. | SPECTACLE, MAGNIFYING | 1988-02-26 | 150 |
| K863994 | Sensory Aids Corp. | VIEWSCAN | 1986-10-31 | 17 |
Recalls for HOT devices
openFDA lists no recalls for product code HOT.
Frequently asked questions
What is FDA product code HOT?
HOT is the FDA product code for aid, vision image intensification. It is a Class I device, regulated under 21 CFR 886.5910 and reviewed by the Ophthalmic panel.
What device class is HOT?
Class I, regulation 21 CFR 886.5910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOT?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most HOT clearances?
Swank Plus , Ltd. (1); Sensory Aids Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOT
- Run a recall and safety report across every HOT manufacturer
- Watch product code HOT 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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