Data / Medical devices / United States / EpiWatch, Inc.
EpiWatch, Inc.: FDA-registered device maker in Baltimore, MD, United States, 1 510(k) clearance
EpiWatch, Inc. is registered with the FDA (registration 3043349255) in Baltimore, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 7, 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
- 3043349255
- Address
- 1812 Ashland Ave Ste 110, Baltimore, MD, United States, 21205
- Owner or operator
- EpiWatch, Inc. (10095197)
- Roles
- Manufacturer
- First device listed
- February 4, 2026
- Registered through
- 2026
- Brand names listed
- EpiWatch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Physiological Signal Based Seizure Monitoring System | POS | 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 |
|---|---|---|---|---|---|---|
| March 7, 2025 | K243515 | EpiWatch Monitoring System | POS | Substantially Equivalent | Epiwatch, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 7, 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.