Cleared Traditional

K893703 - AFTER LOADING DEVICE KIT

K893703 is an FDA 510(k) clearance for AFTER LOADING DEVICE KIT, manufactured by Medical Radiation Devices, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K893703 · Medical Radiation Devices, Inc. · Radiology device
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Sep 1989
Decision
123d
Days
Class 1
Risk

K893703 is an FDA 510(k) clearance for the AFTER LOADING DEVICE KIT. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Medical Radiation Devices, Inc. (Dothan, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - 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 Medical Radiation Devices, Inc. devices

FDA 510(k) Submission Details - K893703

510(k) Number K893703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1989
Decision Date September 18, 1989
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWJ System, Applicator, Radionuclide, Manual

All 23
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K893703.
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K944522 · Medical Device Technologies, Inc. · Feb 1995
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550 · Cook, Inc. · Aug 1994
QUICK SEEDER
K913293 · Mick Radio-Nuclear Instruments, Inc. · Oct 1992
WANG FRONT LOADING APPLICATOR
K890485 · Mick Radio-Nuclear Instruments, Inc. · Apr 1989
HILARIS-NORI CERVIX APPLICATOR
K891377 · Mick Radio-Nuclear Instruments, Inc. · Apr 1989
MICK 200-TP AND MICK TP NEEDLE
K890341 · Mick Radio-Nuclear Instruments, Inc. · Mar 1989