Cleared Traditional

K201185 - microINR System (FDA 510(k) Clearance)

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

K201185 · Iline Microsystems, S.L. · Hematology device
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Dec 2020
Decision
231d
Days
Class 2
Risk

K201185 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. (San Sebastian-Donostia, ES). The FDA issued a Cleared decision on December 18, 2020 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Iline Microsystems, S.L. devices

Submission Details

510(k) Number K201185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date December 18, 2020
Days to Decision 231 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 113d · This submission: 231d
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 K201185.
CoaguChek XS Plus System
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microINR System
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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