Cleared Traditional

K901842 - PLASTIC-GUIDES

K901842 is an FDA 510(k) clearance for PLASTIC-GUIDES, manufactured by M & K Co.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901842 · M & K Co. · Radiology device
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Jul 1990
Decision
78d
Days
Class 1
Risk

K901842 is an FDA 510(k) clearance for the PLASTIC-GUIDES. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by M & K Co. (Tucson, US). The FDA issued a Cleared decision on July 11, 1990 after a review of 78 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 M & K Co. devices

FDA 510(k) Submission Details - K901842

510(k) Number K901842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date July 11, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
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
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