FDA product code HIX: Maxwell Spot, Ac-Powered
HIX is the FDA product code for maxwell spot, ac-powered. It is a Class I device, regulated under 21 CFR 886.1435 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HIX, from 2 different applicants. The average 510(k) review took 80 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Maxwell Spot, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1435 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HIX clearance
Top HIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgidev Corp. | 1 | 1983-10-19 |
| Medi-Spec | 1 | 1980-08-04 |
Most recent HIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831829 | Surgidev Corp. | KARICKHOFF FLYING CORPUSCLE VIEWER | 1983-10-19 | 134 |
| K801554 | Medi-Spec | STERILE CAST PADDING | 1980-08-04 | 27 |
Recalls for HIX devices
openFDA lists no recalls for product code HIX.
Frequently asked questions
What is FDA product code HIX?
HIX is the FDA product code for maxwell spot, ac-powered. It is a Class I device, regulated under 21 CFR 886.1435 and reviewed by the Ophthalmic panel.
What device class is HIX?
Class I, regulation 21 CFR 886.1435. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HIX?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most HIX clearances?
Surgidev Corp. (1); Medi-Spec (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HIX
- Run a recall and safety report across every HIX manufacturer
- Watch product code HIX 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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