Cleared Traditional

K896125 - MEDIPART DISPOSABLE XENON-133 REBREATHI...

K896125 is an FDA 510(k) clearance for MEDIPART DISPOSABLE XENON-133 REBREATHI..., 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 101-day FDA review.

K896125 · Medipart Jerry Alexander · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
101d
Days
Class 2
Risk

K896125 is an FDA 510(k) clearance for the MEDIPART DISPOSABLE XENON-133 REBREATHING 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 February 1, 1990 after a review of 101 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 - K896125

510(k) Number K896125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1989
Decision Date February 01, 1990
Days to Decision 101 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
6d faster than avg
Panel avg: 107d · This submission: 101d
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 K896125.
XENON GAS BREATHING CIRCUIT
K952223 · Intertech Resources, Inc. · Aug 1995
BOLUS XENON CIRCUIT
K912626 · Vital Signs, Inc. · Aug 1991
DISPOSABLE RESPIRTORY KIT (MP-200)
K896885 · Medipart Jerry Alexander · Feb 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
K896124 · Medipart Jerry Alexander · Jan 1990
DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
K896475 · Medipart Jerry Alexander · Jan 1990
DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
K896476 · Medipart Jerry Alexander · Jan 1990