Cleared Traditional

K800134 - HOPE MODEL 126, AUTO/PROCES., DEN. FLM (FDA 510(k) Clearance)

Class I Radiology device.

K800134 · Hope Industries, Inc. · Radiology device
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May 1980
Decision
102d
Days
Class 1
Risk

K800134 is an FDA 510(k) clearance for the HOPE MODEL 126, AUTO/PROCES., DEN. FLM. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by Hope Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - 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 Hope Industries, Inc. devices

Submission Details

510(k) Number K800134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date May 02, 1980
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
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.