Cleared Traditional

K832738 - HEYER-SCHULTE AFTERLOADING CATHETER

K832738 is an FDA 510(k) clearance for HEYER-SCHULTE AFTERLOADING CATHETER, manufactured by American Heyer Schulte. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K832738 · American Heyer Schulte · Radiology device
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Sep 1983
Decision
48d
Days
Class 1
Risk

K832738 is an FDA 510(k) clearance for the HEYER-SCHULTE AFTERLOADING CATHETER. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by American Heyer Schulte (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 48 days - a notably fast clearance cycle.

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: 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 American Heyer Schulte devices

FDA 510(k) Submission Details - K832738

510(k) Number K832738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date September 29, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 107d · This submission: 48d
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 K832738.
KUMAR CERVICAL APPLICATOR
K871213 · Mick Radio-Nuclear Instruments, Inc. · Jul 1987
HENSCHKE AFTERLOADING APPLICATOR
K871217 · Mick Radio-Nuclear Instruments, Inc. · Jul 1987
I-125 IMPLANT GUN
K850571 · Mick Radio-Nuclear Instruments, Inc. · Mar 1985
SCOTT NEEDLE & SCOTT MICK IMPLANTER
K801983 · Mick Radio-Nuclear Instruments, Inc. · Oct 1980
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
K800320 · Amersham Corp. · Mar 1980