Data / Medical devices / United States / QuietLab LLC
QuietLab LLC: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
QuietLab LLC is registered with the FDA (registration 3043364471) in New York, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 5, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3043364471
- Address
- 447 Broadway Fl 2, New York, NY, United States, 10013
- Owner or operator
- QuietLab (10094553)
- Roles
- Specification developer
- First device listed
- January 21, 2026
- Registered through
- 2027
- Brand names listed
- QuietLab Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 5, 2025 | K253868 | QuietLab Pro | LRK | Substantially Equivalent | QuietLab, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 5, 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.