Cleared Traditional

K935649 - WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATI...

K935649 is an FDA 510(k) clearance for WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATI..., manufactured by Bennett X-Ray Corp.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K935649 · Bennett X-Ray Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
78d
Days
Class 2
Risk

K935649 is an FDA 510(k) clearance for the WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Bennett X-Ray Corp. (Copiague, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 78 days - a notably fast clearance cycle.

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: 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 - K935649

510(k) Number K935649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1993
Decision Date February 09, 1994
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
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 191
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K935649.
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K921112 · Fujifilm Medical System U.S.A., Inc. · Apr 1993
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · Hologic, Inc. · Oct 1991