Data / Medical devices / United States / Origin Medical Devices Inc
Origin Medical Devices Inc: FDA-registered device maker in Newport Beach, CA, United States, 1 510(k) clearance
Origin Medical Devices Inc is registered with the FDA (registration 3010088563) in Newport Beach, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010088563
- Address
- 23 Corporate Plaza Suite 150, Newport Beach, CA, United States, 92660
- Owner or operator
- Origin Medical Devices Inc (10081924)
- Roles
- Specification developer
- First device listed
- November 1, 2023
- Registered through
- 2026
- Brand names listed
- Panther 3, Panther 3V, Panther 5, Panther 5N
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | 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 |
|---|---|---|---|---|---|---|
| July 20, 2023 | K213098 | Panther 5 | CBK | Substantially Equivalent | Origin Medical Devices | accessdata.fda.gov |
Compare with other makers
Updated July 20, 2023. 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.