Cleared Traditional

K844495 - MEDIPART XENON BREATHING KIT MP-02XM

K844495 is an FDA 510(k) clearance for MEDIPART XENON BREATHING KIT MP-02XM, 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 27-day FDA review.

K844495 · Medipart Jerry Alexander · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
27d
Days
Class 2
Risk

K844495 is an FDA 510(k) clearance for the MEDIPART XENON BREATHING KIT MP-02XM. 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 December 17, 1984 after a review of 27 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 Medipart Jerry Alexander devices

FDA 510(k) Submission Details - K844495

510(k) Number K844495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1984
Decision Date December 17, 1984
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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 K844495.
MEDIPART XENON BREATHING KIT MP-02XM-I
K850367 · 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
XENON DELIVERY SYSTEM
K820143 · Vital Signs, Inc. · Mar 1982
DISPENSER, GAS XENON
K781107 · Mallinckrodt Critical Care · Jul 1978