Data / Medical devices / United States / Certa Dose
Certa Dose: FDA-registered device maker in Denver, CO, United States, 1 510(k) clearance
Certa Dose is registered with the FDA (registration 3014759854) in Denver, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2017. 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
- 3014759854
- Address
- 2590 Welton Street #200, Denver, CO, United States, 80205
- Owner or operator
- CD Acquisitions, LLC (Certa Dose) (10058186)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 24, 2018
- Registered through
- 2026
- Brand names listed
- Certa Dose PALS Syringe Holder Kit, Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Epinephrine Syringe | PQX | 2 | Complaint file establishment, 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 19, 2017 | K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | PQX | Substantially Equivalent | Certa Dose, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 19, 2017. 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.