Cleared Traditional

xR IVD (K241868) - FDA 510(k) Clearance

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

K241868 · Tempus AI, Inc. · Pathology device
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Sep 2025
Decision
449d
Days
Class 2
Risk

K241868 is an FDA 510(k) clearance for the xR IVD. Classified as Next Generation Sequencing Based Tumor Profiling Test (product code PZM), Class II - Special Controls.

Submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on September 19, 2025 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6080 - the FDA pathology 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 Pathology submissions.

View all Tempus AI, Inc. devices

Submission Details

510(k) Number K241868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2024
Decision Date September 19, 2025
Days to Decision 449 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
372d slower than avg
Panel avg: 77d · This submission: 449d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZM Next Generation Sequencing Based Tumor Profiling Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6080
Definition A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Tumor Specimens Obtained From Patients Diagnosed With Malignant Solid Neoplasms Using Targeted Next-generation Sequencing.
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 Pathology devices follow this clearance model.

Regulatory Peers - PZM Next Generation Sequencing Based Tumor Profiling Test

Devices cleared under the same product code (PZM) and FDA review panel - the closest regulatory comparables to K241868.
CellDx-Tissue
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