Cleared Traditional

K903805 - AMICI XENON ADMINISTRATION SET

K903805 is an FDA 510(k) clearance for AMICI XENON ADMINISTRATION SET, manufactured by Amici, Inc.. The device is a Class 2 Radiology device with product code IYT cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K903805 · Amici, Inc. · Radiology device
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Jan 1991
Decision
152d
Days
Class 2
Risk

K903805 is an FDA 510(k) clearance for the AMICI XENON ADMINISTRATION SET. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Amici, Inc. (Spring City, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 152 days - an extended review 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: 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 Amici, Inc. devices

FDA 510(k) Submission Details - K903805

510(k) Number K903805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1990
Decision Date January 14, 1991
Days to Decision 152 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 107d · This submission: 152d
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 K903805.
XENON CIRCUIT
K953513 · King Systems Corp. · Nov 1995
XENON GAS BREATHING CIRCUIT
K952223 · Intertech Resources, Inc. · Aug 1995
BOLUS XENON CIRCUIT
K912626 · Vital Signs, Inc. · Aug 1991
DISPOSABLE RESPIRTORY KIT (MP-200)
K896885 · Medipart Jerry Alexander · Feb 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
K896125 · Medipart Jerry Alexander · Feb 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
K896124 · Medipart Jerry Alexander · Jan 1990