Cleared Traditional

K902488 - MODIFIED CASS SYSTEM

K902488 is an FDA 510(k) clearance for MODIFIED CASS SYSTEM, manufactured by Medical Instrumentation & Diagnostics Corp.(Midco). The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K902488 · Medical Instrumentation & Diagnostics Corp.(Midco) · Radiology device
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Dec 1990
Decision
191d
Days
Class 2
Risk

K902488 is an FDA 510(k) clearance for the MODIFIED CASS SYSTEM. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Medical Instrumentation & Diagnostics Corp.(Midco) (Albuquerque, US). The FDA issued a Cleared decision on December 7, 1990 after a review of 191 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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.

FDA 510(k) Submission Details - K902488

510(k) Number K902488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date December 07, 1990
Days to Decision 191 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
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K902488.
I-125 SEEDS, CODE: 6711
K914281 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Nov 1991
RADIOACTIVE SEEDS
K910710 · Best Assoc. Corp. · Jun 1991
OMNICATH IMPLANTED CATHETER AND DEPOT
K911775 · Omnitron Intl., Inc. · May 1991
IR-192 IMPLANT
K903465 · Rads S.L., Inc. · Oct 1990
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990
COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT
K896197 · Colab Intl., Inc. · Jul 1990
K902488 · MODIFIED CASS SYSTEM
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