Cleared Traditional

K201185 - microINR System

K201185 is an FDA 510(k) clearance for microINR System, manufactured by Iline Microsystems, S.L.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 231-day FDA review.

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

FDA 510(k) Submission Details - K201185

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
Combination Product No
PCCP Authorized No
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.

GJS Device Classification - Class 2, Special Controls

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 Consultant

Zivd, LLC
Marcia L Zucker

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GJS Test, Time, Prothrombin

All 102
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K201185.
STA- NeoPTimal
K211485 · Diagnostica Stago S.A.S · Dec 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
K212779 · Coagusense, Inc. · Oct 2022
HemosIL ReadiPlasTin
K213426 · Instrumentation Laboratory CO · Aug 2022
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
K183255 · Coagusense, Inc. · Feb 2019
microINR System
K180780 · Iline Microsystems, S.L. · Jan 2019
CoaguChek XS Plus System
K180684 · Roche Diagnostics · Apr 2018