Cleared Special

K251968 - HemosIL Fibrinogen-C (FDA 510(k) Clearance)

Also includes:
HemosIL Fibrinogen-C XL

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

K251968 · Instrumentation Laboratory (IL) Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
28d
Days
Class 2
Risk

K251968 is an FDA 510(k) clearance for the HemosIL Fibrinogen-C. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on July 24, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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 Instrumentation Laboratory (IL) Co. devices

Submission Details

510(k) Number K251968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2025
Decision Date July 24, 2025
Days to Decision 28 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
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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.