Cleared Traditional

K854110 - KEITHLEY MODEL 75100 & 75200

K854110 is an FDA 510(k) clearance for KEITHLEY MODEL 75100 & 75200, manufactured by Keithley Instruments, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K854110 · Keithley Instruments, Inc. · Radiology device
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Mar 1986
Decision
149d
Days
Class 2
Risk

K854110 is an FDA 510(k) clearance for the KEITHLEY MODEL 75100 & 75200. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Keithley Instruments, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 149 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 Keithley Instruments, Inc. devices

FDA 510(k) Submission Details - K854110

510(k) Number K854110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date March 06, 1986
Days to Decision 149 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 107d · This submission: 149d
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 K854110.
BC 1400 HAND POSITIONER
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BC 1800 FINGER POSITIONER
K872317 · Instrumentation Industries, Inc. · Aug 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987
DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
K853753 · Victoreen, Inc. · Oct 1985
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · General Electric Co. · Dec 1981
DSS 500
K811934 · Philips Medical Systems (Cleveland), Inc. · Aug 1981