Data / Medical devices / United States / Iris Usa Inc
Iris Usa Inc: FDA-registered device maker in Pleasant Prairie, WI, United States, 1 510(k) clearance
Iris Usa Inc is registered with the FDA (registration 3002813051) in Pleasant Prairie, WI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002813051
- Address
- 11111 80th Ave, Pleasant Prairie, WI, United States, 53158
- Owner or operator
- IRIS USA INC (10093997)
- Roles
- Manufacturer
- First device listed
- September 5, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2023 | K230380 | Surgical Face Masks, Model: EFMDS-L50Pn BLU | FXX | Substantially Equivalent | Iris USA | accessdata.fda.gov |
Compare with other makers
Updated August 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.