Cleared Traditional

K070005 - HEMOSIL RECOMBIPLASTIN 2G

K070005 is the FDA 510(k) clearance for HEMOSIL RECOMBIPLASTIN 2G by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K070005 · Instrumentation Laboratory CO · Hematology device
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Aug 2007
Decision
224d
Days
Class 2
Risk

K070005 is an FDA 510(k) clearance for the HEMOSIL RECOMBIPLASTIN 2G. 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 August 15, 2007 after a review of 224 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K070005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date August 15, 2007
Days to Decision 224 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
111d slower than avg
Panel avg: 113d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 76
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K070005.
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