Data / Medical devices / United States / Splintek Inc.
Splintek Inc.: FDA-registered device maker in Lenexa, KS, United States, 1 510(k) clearance
Splintek Inc. is registered with the FDA (registration 3003460151) in Lenexa, KS, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003460151
- FEI number
- 3003322666
- Address
- 15555 W 108th Street, Lenexa, KS, United States, 66219
- Owner or operator
- Splintek Inc. (9047750)
- Roles
- Manufacturer
- First device listed
- March 12, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 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 |
|---|---|---|---|---|---|---|
| May 19, 2025 | K250122 | SleepRight Snore Aid | LRK | Substantially Equivalent | Splintek, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 19, 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.