Cleared Traditional

PATHFAST D-DIMER (K072288) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072288 · Mitsubishi Kagaku Iatron · Hematology device
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May 2009
Decision
629d
Days
Class 2
Risk

K072288 is an FDA 510(k) clearance for the PATHFAST D-DIMER. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on May 6, 2009 after a review of 629 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Mitsubishi Kagaku Iatron devices

Submission Details

510(k) Number K072288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date May 06, 2009
Days to Decision 629 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
516d slower than avg
Panel avg: 113d · This submission: 629d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHH Fibrin Split Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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.