FDA product code MSI: Solution, Cleaning / Lubricating, Artificial Eye
MSI is the FDA product code for solution, cleaning / lubricating, artificial eye. It is a Class III device, reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under MSI. The average 510(k) review took 174 days (median 174). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Cleaning / Lubricating, Artificial Eye |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Top MSI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sacks Model Makers | 1 | 1989-11-14 |
Most recent MSI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893829 | Sacks Model Makers | POWERED EYE WASH | 1989-11-14 | 174 |
Recalls for MSI devices
openFDA lists no recalls for product code MSI.
Frequently asked questions
What is FDA product code MSI?
MSI is the FDA product code for solution, cleaning / lubricating, artificial eye. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is MSI?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code MSI?
Across 1 cleared submissions the average was 174 days from receipt to decision (median 174).
Which companies have the most MSI clearances?
Sacks Model Makers (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MSI
- Run a recall and safety report across every MSI manufacturer
- Watch product code MSI 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.