Cleared Traditional

PINK CASSETTE CADDIE (K893728) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893728 · Medical Technique Instruments, Inc. · Radiology device
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Sep 1989
Decision
124d
Days
Class 2
Risk

K893728 is an FDA 510(k) clearance for the PINK CASSETTE CADDIE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Medical Technique Instruments, Inc. (Kirkland, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1850 - 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 Technique Instruments, Inc. devices

Submission Details

510(k) Number K893728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date September 18, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 107d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 20
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K893728.
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · Eastman Kodak Company · Aug 1992
DU PONT MAMMOGRAPHY CASSETTE
K900620 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
KODAK X-OMATIC RA CASSETTE
K890750 · Eastman Kodak Company · Mar 1989
KODAK MIN-R 2 CASSETTE
K890361 · Eastman Kodak Company · Feb 1989
KODAFLEX II RADIATION THERAPY L CASSETTE
K885178 · Eastman Kodak Company · Feb 1989