Data / Medical devices / United States / Earflo Company
Earflo Company: FDA-registered device maker in Pittsburgh, PA, United States, 1 510(k) clearance
Earflo Company is registered with the FDA (registration 3043739646) in Pittsburgh, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043739646
- Address
- 203 Lothrop St Suite 500, Pittsburgh, PA, United States, 15213
- Owner or operator
- Earflo Inc. (10095482)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 18, 2026
- Registered through
- 2026
- Brand names listed
- Earflo EF001 Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Inflation, Middle Ear | MJV | U | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 10, 2026 | K252751 | Earflo (EF001) | MJV | Substantially Equivalent | Earflo, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 10, 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.