FDA applicant
Asset Medikal Tasarim As.
FDA records 4 decisions for Asset Medikal Tasarim As. (Istanbul, TR) from 2020 to 2022: 4 510(k) clearances. All are in product code FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 213 for FDA’s reviews in the same codes and years. 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 Asset Medikal Tasarim As.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Asset Medikal Tasarim As.’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) ReportOther applicant names beginning “Asset”
FDA records each applicant name separately; these may or may not be the same firm.