Cleared Special

K160445 - HemosIL Silica Clotting Time

K160445 is an FDA 510(k) clearance for HemosIL Silica Clotting Time, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GFO cleared through the Special 510(k) pathway after a 28-day FDA review.

K160445 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
28d
Days
Class 2
Risk

K160445 is an FDA 510(k) clearance for the HemosIL Silica Clotting Time. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 16, 2016 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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.

FDA 510(k) Submission Details - K160445

510(k) Number K160445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2016
Decision Date March 16, 2016
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.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 51
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K160445.
HemosIL Silica Clotting Time
K253957 · Instrumentation Laboratory (IL) Co. · Jan 2026
Cryocheck Hex LA
K193556 · Precision Biologic · Oct 2020
STA-CEPHASCREEN KIT
K053111 · Diagnostica Stago, Inc. · May 2006
HEMOSIL SYNTHASIL
K060688 · Instrumentation Laboratory CO · Apr 2006
HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · Vital Scientific N.V. · Nov 2002
K160445 · HemosIL Silica Clotting Time
Download PDF FDA Summary Instrumentation Labor…