Data / Medical devices / United States / Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc.: FDA-registered device maker in Lakewood, CO, United States, 3 510(k) clearances
Prytime Medical Devices, Inc. is registered with the FDA (registration 3012279212) in Lakewood, CO, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012279212
- Address
- 575 Union Blvd Suite 107, Lakewood, CO, United States, 80228
- Owner or operator
- Prytime Medical Devices, Inc. (10050783)
- Roles
- Specification developer
- First device listed
- May 3, 2017
- Registered through
- 2026
- Brand names listed
- ER-REBOA 2 Catheter, ER-REBOA PLUS Catheter, REBOA Catheter Compass Convenience Set, REBOA Catheter Convenience Set, pREBOA-PRO Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter Introducer Kit | OFC | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 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 |
|---|---|---|---|---|---|---|
| September 5, 2025 | K243795 | pREBOA-PRO Catheter | MJN | Substantially Equivalent | Prytime Medical Devices, Inc. | accessdata.fda.gov |
| June 3, 2020 | K200459 | pREBOA-PRO Catheter | MJN | Substantially Equivalent | Prytime Medical Devices, Inc. | accessdata.fda.gov |
| January 9, 2020 | K193440 | ER-REBOA PLUS Catheter | MJN | Substantially Equivalent | Prytime Medical Devices, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular Occluding, Temporary
- All makers of Catheter, Percutaneous
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter Introducer Kit
Updated September 5, 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.