Cleared Special

K132722 - HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)

K132722 is the FDA 510(k) clearance for HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJS) cleared through the Special 510(k) pathway after a 145-day FDA review.

K132722 · Instrumentation Laboratory CO · Hematology device
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Jan 2014
Decision
145d
Days
Class 2
Risk

K132722 is an FDA 510(k) clearance for the HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL). Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 145 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K132722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2013
Decision Date January 22, 2014
Days to Decision 145 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 113d · This submission: 145d
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 75
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