Cleared Traditional

K260755 - OptraSCAN System

K260755 · Optrascan, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
115d
Days
-
Risk

K260755 is an FDA 510(k) clearance for the OptraSCAN System.

Submitted by Optrascan, Inc. (San Jose, US). The FDA issued a Cleared decision on July 2, 2026 after a review of 115 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 Optrascan, Inc. devices

FDA 510(k) Submission Details - K260755

510(k) Number K260755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2026
Decision Date July 02, 2026
Days to Decision 115 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 78d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

NOT Device Classification - Class ,

Product Code NOT
Device Class -

Regulatory Consultant

Addwin Consulting
Mona Advani

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NOT

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