Cleared Traditional

K843640 - XENON XE 127/XE 133 GAS DISPENSER

K843640 is the FDA 510(k) clearance for XENON XE 127/XE 133 GAS DISPENSER by Mallinckrodt Critical Care. It is a Class 2 Radiology device (product code IYT) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K843640 · Mallinckrodt Critical Care · Radiology device
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Jan 1985
Decision
119d
Days
Class 2
Risk

K843640 is an FDA 510(k) clearance for the XENON XE 127/XE 133 GAS DISPENSER. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (St. Louis, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 119 days - within the typical 510(k) review window.

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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K843640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date January 14, 1985
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
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.

Regulatory Peers - IYT System, Rebreathing, Radionuclide

All 29
Devices cleared under the same product code (IYT) and FDA review panel - the closest regulatory comparables to K843640.
RESPIR GARD-II FACE MASK CORRUGATED TUBING
K853056 · Marquest Medical Products, Inc. · Aug 1985
MEDIPART XENON BREATHING KIT MP-OIXM-I
K850366 · Medipart Jerry Alexander · Apr 1985
MEDIPART XENON BREATHING KIT MP-02XM-I
K850367 · Medipart Jerry Alexander · Apr 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