Data / Medical devices / United States / Innovacyn, Inc.
Innovacyn, Inc.: FDA-registered device maker in Rialto, CA, United States, 3 510(k) clearances
Innovacyn, Inc. is registered with the FDA (registration 3008750913) in Rialto, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008750913
- Address
- 3546 N Riverside Ave, Rialto, CA, United States, 92377
- Owner or operator
- Innovacyn, Inc. (10046918)
- Roles
- Manufacturer
- First device listed
- May 30, 2014
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 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 |
|---|---|---|---|---|---|---|
| January 5, 2026 | K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | FRO | Substantially Equivalent | Innovacyn, Inc. | accessdata.fda.gov |
| November 19, 2015 | K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | FRO | Substantially Equivalent | Innovacyn, Inc. | accessdata.fda.gov |
| April 28, 2014 | K133542 | PURACYN PLUS SKIN AND WOUND | FRO | Substantially Equivalent | Innovacyn, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 5, 2026. 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.