Cleared Traditional

K891403 - HUGH YOUNG II UROLOGICAL TABLE

K891403 is the FDA 510(k) clearance for HUGH YOUNG II UROLOGICAL TABLE by Mallinckrodt Group, Inc.. It is a Class 2 Radiology device (product code IZZ) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K891403 · Mallinckrodt Group, Inc. · Radiology device
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Jun 1989
Decision
100d
Days
Class 2
Risk

K891403 is an FDA 510(k) clearance for the HUGH YOUNG II UROLOGICAL TABLE. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Mallinckrodt Group, Inc. devices

Submission Details

510(k) Number K891403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date June 22, 1989
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZZ Table, Radiographic, Non-tilting, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IZZ Table, Radiographic, Non-tilting, Powered

All 13
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K891403.
SHIMADZU RADIOGRAPHIC TABLE BK-100
K925174 · Shimadzu Medical Systems · Nov 1992
CATHERIZATION KS-50
K920732 · Shimadzu Medical Systems · Apr 1992
CAT-250B
K915413 · Toshiba America Medical Systems, In.C · Dec 1991
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · Warner-Lambert Co. · Jun 1989
COMPAX MODEL 40, 400, 400T
K884930 · General Electric Co. · Dec 1988
TANGENT II
K883974 · Fischer Imaging Corp. · Oct 1988