510(k) Report

FDA applicant

Asset Medikal Tasarim As.

Istanbul, TR4 decisions2020–20220 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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

2020: 12021: 12022: 2
2020high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Asset Medikal Tasarim As. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Asset”

FDA records each applicant name separately; these may or may not be the same firm.