Cleared Traditional

K850367 - MEDIPART XENON BREATHING KIT MP-02XM-I

K850367 is an FDA 510(k) clearance for MEDIPART XENON BREATHING KIT MP-02XM-I, manufactured by Medipart Jerry Alexander. The device is a Class 2 Radiology device with product code IYT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K850367 · Medipart Jerry Alexander · Radiology device
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Apr 1985
Decision
90d
Days
Class 2
Risk

K850367 is an FDA 510(k) clearance for the MEDIPART XENON BREATHING KIT MP-02XM-I. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on April 30, 1985 after a review of 90 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 Medipart Jerry Alexander devices

FDA 510(k) Submission Details - K850367

510(k) Number K850367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date April 30, 1985
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 29
Devices cleared under the same product code (IYT) and FDA review panel - the closest regulatory comparables to K850367.
MEDIPART FACE MASK & FILTER MP-30XM-I
K850837 · Medipart Jerry Alexander · Aug 1985
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
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