Cleared Traditional

K820571 - XENAMATIC SERIES OF XENON REBREATH DEV

K820571 is an FDA 510(k) clearance for XENAMATIC SERIES OF XENON REBREATH DEV, manufactured by Diversified P.A.. The device is a Class 2 Radiology device with product code IYT cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K820571 · Diversified P.A. · Radiology device
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Mar 1982
Decision
29d
Days
Class 2
Risk

K820571 is an FDA 510(k) clearance for the XENAMATIC SERIES OF XENON REBREATH DEV. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Diversified P.A. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982 after a review of 29 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 Diversified P.A. devices

FDA 510(k) Submission Details - K820571

510(k) Number K820571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date March 31, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IYT System, Rebreathing, Radionuclide

All 32
Devices cleared under the same product code (IYT) and FDA review panel - the closest regulatory comparables to K820571.
XENON XE 127/XE 133 GAS DISPENSER
K843640 · Mallinckrodt Critical Care · Jan 1985
MEDIPART XENON BREATHING KIT MP-01XM
K844496 · Medipart Jerry Alexander · Dec 1984
MEDIPART XENON BREATHING KIT MP-02XM
K844495 · Medipart Jerry Alexander · Dec 1984
XENON DELIVERY SYSTEM
K820143 · Vital Signs, Inc. · Mar 1982
DISPENSER, GAS XENON
K781107 · Mallinckrodt Critical Care · Jul 1978