Cleared Traditional

K810819 - MEDI/NUCLEAR #XE-102 XENON/MASTER (FDA 510(k) Clearance)

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

K810819 · Medi Nuclear Corp., Inc. · Radiology device
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Apr 1981
Decision
21d
Days
Class 2
Risk

K810819 is an FDA 510(k) clearance for the MEDI/NUCLEAR #XE-102 XENON/MASTER. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Medi Nuclear Corp., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1390 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medi Nuclear Corp., Inc. devices

Submission Details

510(k) Number K810819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date April 14, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYT System, Rebreathing, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1390
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.