Cleared Traditional

K891395 - RADKOR BS-10 AND BS-10T

K891395 is an FDA 510(k) clearance for RADKOR BS-10 AND BS-10T, manufactured by Radkor, Inc.. The device is a Class 1 Radiology device with product code IXY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K891395 · Radkor, Inc. · Radiology device
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Apr 1989
Decision
20d
Days
Class 1
Risk

K891395 is an FDA 510(k) clearance for the RADKOR BS-10 AND BS-10T. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Radkor, Inc. (Irvine, US). The FDA issued a Cleared decision on April 3, 1989 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - 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 Radkor, Inc. devices

FDA 510(k) Submission Details - K891395

510(k) Number K891395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date April 03, 1989
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

IXY Device Classification - Class 1, General Controls

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
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 - IXY Holder, Radiographic Cassette, Wall-mounted

All 7
Devices cleared under the same product code (IXY) and FDA review panel - the closest regulatory comparables to K891395.
VRS 3 WALL STAND
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MULTI-SIZE CASSETTE HOLDER
K850125 · Philips Medical Systems (Cleveland), Inc. · Mar 1985