Cleared Traditional

K843640 - XENON XE 127/XE 133 GAS DISPENSER

K843640 is an FDA 510(k) clearance for XENON XE 127/XE 133 GAS DISPENSER, manufactured by Mallinckrodt Critical Care. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K843640

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.

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 31
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