Cleared Traditional

K933778 - WHITMORE ANKLE X-RAY EXTENSION (AXE)

K933778 is an FDA 510(k) clearance for WHITMORE ANKLE X-RAY EXTENSION (AXE), manufactured by Whitmore Ent., Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K933778 · Whitmore Ent., Inc. · Radiology device
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Dec 1993
Decision
132d
Days
Class 2
Risk

K933778 is an FDA 510(k) clearance for the WHITMORE ANKLE X-RAY EXTENSION (AXE). Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Whitmore Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Whitmore Ent., Inc. devices

FDA 510(k) Submission Details - K933778

510(k) Number K933778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date December 13, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 297
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K933778.
BUCKY STAND BR-10M
K942792 · Shimadzu Corp. · Jul 1994
DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
K941931 · Victoreen, Inc. · May 1994
WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY
K935649 · Bennett X-Ray Corp. · Feb 1994
SHIMADZU CEILING TUBE SUPPORT CH-30GX
K934005 · Shimadzu Corp. · Nov 1993
FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK
K921112 · Fujifilm Medical System U.S.A., Inc. · Apr 1993
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · Hologic, Inc. · Oct 1991