Data / Medical devices / United States / Vault Paragon Group, Inc.
Vault Paragon Group, Inc.: FDA-registered device maker in Garden City, ID, United States, 1 510(k) clearance
Vault Paragon Group, Inc. is registered with the FDA (registration 3018681450) in Garden City, ID, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018681450
- Address
- 199 E 52nd Street Ste. 150, Garden City, ID, United States, 83714
- Owner or operator
- VAULT PARAGON GROUP INC (10081504)
- Roles
- Complaint file establishment, Contract manufacturer, Specification developer
- First device listed
- February 14, 2023
- Registered through
- 2026
- Brand names listed
- Aeroject Syringe, VaporShield
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Contract 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 |
|---|---|---|---|---|---|---|
| January 25, 2023 | K220114 | PowerPAK Syringe | MEG | Substantially Equivalent | Vault Paragon Group, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Updated January 25, 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.