Cleared Traditional

K141109 - APERIO EPATHOLOGY EIHC IVD SYSTEM (FDA 510(k) Clearance)

K141109 · Leica Biosystems Imaging, Inc. · Pathology device
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Jul 2014
Decision
91d
Days
-
Risk

K141109 is an FDA 510(k) clearance for the APERIO EPATHOLOGY EIHC IVD SYSTEM.

Submitted by Leica Biosystems Imaging, Inc. (Vista, US). The FDA issued a Cleared decision on July 29, 2014 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel. 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Leica Biosystems Imaging, Inc. devices

Submission Details

510(k) Number K141109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date July 29, 2014
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 77d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -