Data / Medical devices / United States / Epic Systems Corporation
Epic Systems Corporation: FDA-registered device maker in Verona, WI, United States, 1 510(k) clearance
Epic Systems Corporation is registered with the FDA (registration 3006365377) in Verona, WI, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006365377
- Address
- 1979 Milky Way, Verona, WI, United States, 53593
- Owner or operator
- Epic Systems Corporation (10046589)
- Roles
- Manufacturer
- First device listed
- July 25, 2017
- Registered through
- 2027
- Brand names listed
- Automated Wound Measurements, Blood Product Administration Module (BPAM 4-2023), Blood Product Administration Module 3-2020, Blood Product Administration Module Version 2-2017, Deterioration Index Version 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Establishment Computer Software And Accessories | MMH | 2 | Manufacturer | accessdata.fda.gov |
| Medium-Term Adjunctive Predictive Cardiovascular Indicator | QNL | 2 | Manufacturer | accessdata.fda.gov |
| Tape, Camera, Surgical | FXN | 1 | 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 |
|---|---|---|---|---|---|---|
| September 18, 2026 | K260008 | Deterioration Index Version 2 | QNL | Substantially Equivalent | Epic Systems Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Establishment Computer Software And Accessories
- All makers of Medium-Term Adjunctive Predictive Cardiovascular Indicator
- All makers of Tape, Camera, Surgical
Updated September 18, 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.