Cleared Traditional

K853576 - MEDIPART DISPOS. XENON 133 ADMIN. SET M...

K853576 is an FDA 510(k) clearance for MEDIPART DISPOS. XENON 133 ADMIN. SET M..., 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 73-day FDA review.

K853576 · Medipart Jerry Alexander · Radiology device
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Nov 1985
Decision
73d
Days
Class 2
Risk

K853576 is an FDA 510(k) clearance for the MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M. 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 November 7, 1985 after a review of 73 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 - K853576

510(k) Number K853576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date November 07, 1985
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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 K853576.
MP-070 RADIOAEROSOL KIT
K862794 · Medipart Jerry Alexander · Aug 1986
MP-070-M RADIOAEROSOL KIT
K862795 · Medipart Jerry Alexander · Aug 1986
MEDIPART DRIERITE MP-1002
K853570 · Medipart Jerry Alexander · Nov 1985
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
K853579 · Medipart Jerry Alexander · Nov 1985
MEDIPART LUNG AEROSOL KIT MP-1012A
K851198 · Medipart Jerry Alexander · Sep 1985
MEDIPART LUNG AEROSOL KIT MP-1012A-M
K851199 · Medipart Jerry Alexander · Sep 1985