Data / Medical devices / United States / Medsafety Solutions LLC
Medsafety Solutions LLC: FDA-registered device maker in Centennial, CO, United States, 2 510(k) clearances
Medsafety Solutions LLC is registered with the FDA (registration 3013445787) in Centennial, CO, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 29, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013445787
- Address
- 11233 E. Caley Avenue Suite 300, Centennial, CO, United States, 80111
- Owner or operator
- MedSafety Solutions LLC (10053688)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 30, 2016
- Registered through
- 2027
- Brand names listed
- Female Luer Lock Cap, KWIK VIAL, Kwik Vial, KwikDose, KwikVial, TwoFer Transfer Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 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 |
|---|---|---|---|---|---|---|
| October 29, 2020 | K200425 | Female Luer Lock Cap | FPA | Substantially Equivalent | Medsafety Solutions, LLC | accessdata.fda.gov |
| September 12, 1983 | K832347 | TWOFER NEEDLE | LHI | Substantially Equivalent | Baxa Corp., Sub. of Cook Group, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Dispenser, Liquid Medication
- All makers of Set, Administration, Intravascular
Updated October 29, 2020. 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.