Cleared Traditional

K260023 - TumorSight Risk

K260023 · SimBioSys, Inc. · Pathology device
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Sep 2026
Decision
263d
Days
-
Risk

K260023 is an FDA 510(k) clearance for the TumorSight Risk.

Submitted by SimBioSys, Inc. (Chicago, US). The FDA issued a Cleared decision on September 25, 2026 after a review of 263 days - an extended review cycle.

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 SimBioSys, Inc. devices

FDA 510(k) Submission Details - K260023

510(k) Number K260023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2026
Decision Date September 25, 2026
Days to Decision 263 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
185d slower than avg
Panel avg: 78d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

SHW Device Classification - Class ,

Product Code SHW
Device Class -

Regulatory Consultant

Hogan Lovells US LLP
John Smith

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.