Cleared Traditional

K043459 - HEMOSIL FACTOR XII DEFICIENT PLASMA

K043459 is the FDA 510(k) clearance for HEMOSIL FACTOR XII DEFICIENT PLASMA by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K043459 · Instrumentation Laboratory CO · Hematology device
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Feb 2005
Decision
56d
Days
Class 2
Risk

K043459 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 February 9, 2005 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K043459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date February 09, 2005
Days to Decision 56 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
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 55
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K043459.
HemosIL Factor XII Deficient Plasma
K180486 · Instrumentation Laboratory CO · Mar 2018
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · Instrumentation Laboratory CO · Jul 2011
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · Instrumentation Laboratory CO · May 2005
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · Instrumentation Laboratory CO · Feb 2004
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · Instrumentation Laboratory CO · Jul 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122 · Instrumentation Laboratory CO · May 2003