Cleared Traditional

K914944 - BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC

K914944 is an FDA 510(k) clearance for BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC, manufactured by Bennett X-Ray Corp.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K914944 · Bennett X-Ray Corp. · Radiology device
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Dec 1991
Decision
28d
Days
Class 1
Risk

K914944 is an FDA 510(k) clearance for the BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Bennett X-Ray Corp. (Copiague, US). The FDA issued a Cleared decision on December 2, 1991 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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 Bennett X-Ray Corp. devices

FDA 510(k) Submission Details - K914944

510(k) Number K914944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date December 02, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

IYB Device Classification - Class 1, General Controls

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
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 - IYB Tube Mount, X-ray, Diagnostic

All 16
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K914944.
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC
K925716 · Bennett X-Ray Corp. · Dec 1992
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ER-1000 CATHERIZATION C-ARM SYSTEMS
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INVENTOR RT/EXPLORER TRAUMA UNIT
K911563 · Continental X-Ray Corp. · Oct 1991
TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL
K912696 · Bennett X-Ray Corp. · Sep 1991