FDA applicant
Zien Medical Technologies, Inc.
FDA records 2 decisions for Zien Medical Technologies, Inc. (Salt Lake City, UT) from 2022 to 2024: 2 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zien Medical Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Zien Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report