Cleared Traditional

K251401 - PennPET Explorer Positron Emission Tomo...

K251401 is an FDA 510(k) clearance for PennPET Explorer Positron Emission Tomo..., manufactured by Trustees of the University of Pennsylvania. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K251401 · Trustees of the University of Pennsylvania · Radiology device
Download Printable Device Report (PDF)
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Nov 2025
Decision
203d
Days
Class 2
Risk

K251401 is an FDA 510(k) clearance for the PennPET Explorer Positron Emission Tomograph. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Trustees of the University of Pennsylvania (Philadelphia, US). The FDA issued a Cleared decision on November 25, 2025 after a review of 203 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trustees of the University of Pennsylvania devices

FDA 510(k) Submission Details - K251401

510(k) Number K251401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2025
Decision Date November 25, 2025
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 248
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