Cleared Special

K132722 - HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)

K132722 is an FDA 510(k) clearance for HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL), manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with 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.

FDA 510(k) Submission Details - K132722

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.

GJS Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K132722.
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INRATIO2 PI/NR MONITORING SYSTEM
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INRATIO/INRATIO2 TEST STRIPS
K092987 · Biosite Incorporated · Jun 2010
K132722 · HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
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