Cleared Traditional

K865107 - AERO-VENT AEROSOL UNIT

K865107 is an FDA 510(k) clearance for AERO-VENT AEROSOL UNIT, manufactured by Medi Nuclear Corp., Inc.. The device is a Class 2 Radiology device with product code IYT cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K865107 · Medi Nuclear Corp., Inc. · Radiology device
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Oct 1987
Decision
293d
Days
Class 2
Risk

K865107 is an FDA 510(k) clearance for the AERO-VENT AEROSOL UNIT. Classified as System, Rebreathing, Radionuclide (product code IYT), Class II - Special Controls.

Submitted by Medi Nuclear Corp., Inc. (Baldwin Park, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 293 days - an extended review 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: 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 Medi Nuclear Corp., Inc. devices

FDA 510(k) Submission Details - K865107

510(k) Number K865107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1986
Decision Date October 20, 1987
Days to Decision 293 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 107d · This submission: 293d
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 30
Devices cleared under the same product code (IYT) and FDA review panel - the closest regulatory comparables to K865107.
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
MP-30XM-IE FACE MASK AND FILTER KIT
K862791 · Medipart Jerry Alexander · Aug 1986
MP-066 RADIOAEROSOL KIT
K862792 · Medipart Jerry Alexander · Aug 1986
MP-066-M RADIOAEROSOL KIT
K862793 · Medipart Jerry Alexander · Aug 1986