Cleared Special

K231711 - microINR System (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231711 · Iline Microsystems, S.L. · Hematology device
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Jul 2023
Decision
29d
Days
Class 2
Risk

K231711 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 July 11, 2023 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Iline Microsystems, S.L. devices

Submission Details

510(k) Number K231711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2023
Decision Date July 11, 2023
Days to Decision 29 days
Submission Type Special
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
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K231711.
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