Data / Medical devices / United States / Seriously Clean Ltd
Seriously Clean Ltd: FDA-registered device maker in Nixa, MO, United States, 2 510(k) clearances
Seriously Clean Ltd is registered with the FDA (registration 3010067148) in Nixa, MO, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010067148
- Address
- 1075 W Kathryn St Ste 6, Nixa, MO, United States, 65714
- Owner or operator
- Seriously Clean Ltd (10042789)
- Roles
- Manufacturer
- First device listed
- December 30, 2012
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K243457 | Nixall Antimicrobial Solutions Skin & Wound Hydrogel | FRO | Substantially Equivalent | Seriously Clean, Ltd. | accessdata.fda.gov |
| December 11, 2012 | K113693 | NIXALL TM WOUND AND SKIN CARE | FRO | Substantially Equivalent | Seriously Clean, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 2, 2025. 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.