Cleared Traditional

K800134 - HOPE MODEL 126, AUTO/PROCES., DEN. FLM

K800134 is an FDA 510(k) clearance for HOPE MODEL 126, manufactured by Hope Industries, Inc.. The device is a Class 1 Radiology device with product code IWZ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K800134 · Hope Industries, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K800134

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.

IWZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - IWZ Film, Radiographic

All 21
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K800134.
KODAK CINEFLUOROGRAPHIC FILM SO-274
K813005 · Eastman Kodak Company · Nov 1981
KODAK ORTHO L FILM
K802171 · Eastman Kodak Company · Oct 1980
KODAK EKTASPEED DENTAL X-RAY FILM
K800901 · Eastman Kodak Company · May 1980
KODAK CFN FILM SO-224
K792178 · Eastman Kodak Company · Jan 1980
KODAK ORTHO G FILM
K792293 · Eastman Kodak Company · Jan 1980
SR 301 MEDICAL X-RAY FILM
K792317 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1980