Cleared Traditional

K251564 - microINR System (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K251564 is an FDA 510(k) clearance for the microINR System. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Iline Microsystems, S.L. (Donostia, ES). The FDA issued a Cleared decision on July 21, 2025 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iline Microsystems, S.L. devices

Submission Details

510(k) Number K251564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 126
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K251564.
CoaguChek XS Plus System
K253188 · Roche Diagnostics · Oct 2025
microINR System
K243543 · Iline Microsystems, S.L. · Feb 2025
Xprecia Prime Coagulation System
K230802 · Universal Biosensors Pty, Ltd. · Mar 2024
i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · Abbott Laboratories · Jul 2023
microINR System
K231711 · Iline Microsystems, S.L. · Jul 2023
STA- NeoPTimal
K211485 · Diagnostica Stago S.A.S · Dec 2022