Data / Medical devices / United States / Staclear, Inc.
Staclear, Inc.: FDA-registered device maker in Raleigh, NC, United States, 3 510(k) clearances
Staclear, Inc. is registered with the FDA (registration 3026478941) in Raleigh, NC, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 21, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3026478941
- Address
- 7250 ACC Blvd., Raleigh, NC, United States, 27617
- Owner or operator
- StaClear, Inc. (10088128)
- Roles
- Manufacturer
- First device listed
- May 30, 2023
- Registered through
- 2027
- Brand names listed
- StaClear, StaClear Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmic Syringe | QLY | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| November 21, 2025 | K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | QLY | Substantially Equivalent | Staclear, Inc. | accessdata.fda.gov |
| April 3, 2025 | K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | QLY | Substantially Equivalent | Staclear, Inc. | accessdata.fda.gov |
| July 27, 2020 | K200242 | StaClear Syringe | QLY | Substantially Equivalent | Tribofilm Research, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ophthalmic Syringe
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
Updated November 21, 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.