Cleared Traditional

microINR System

K251564 · Iline Microsystems, S.L. · Hematology
Jul 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K251564 is an FDA 510(k) clearance for the microINR System, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Iline Microsystems, S.L. (Donostia, ES). The FDA issued a Cleared decision on July 21, 2025, 60 days after receiving the submission on May 22, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K251564 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date July 21, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750