Cleared Special

HemosIL Factor XII Deficient Plasma (K180486) - FDA 510(k) Clearance

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

K180486 · Instrumentation Laboratory CO · Hematology device
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Mar 2018
Decision
27d
Days
Class 2
Risk

K180486 is an FDA 510(k) clearance for the HemosIL Factor XII Deficient Plasma. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 22, 2018 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 CO devices

Submission Details

510(k) Number K180486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2018
Decision Date March 22, 2018
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 78
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K180486.
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831 · Precision Biologic, Inc. · Sep 2023
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · Instrumentation Laboratory CO · Jul 2011
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · Instrumentation Laboratory CO · May 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459 · Instrumentation Laboratory CO · Feb 2005
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · Instrumentation Laboratory CO · Feb 2004
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · Instrumentation Laboratory CO · Jul 2003