Cleared Traditional

KODAK MEDICAL X-RAY DEVELOPER & REPLEN. (K801209) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801209 · Eastman Kodak Company · Radiology device
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Jun 1980
Decision
37d
Days
Class 2
Risk

K801209 is an FDA 510(k) clearance for the KODAK MEDICAL X-RAY DEVELOPER & REPLEN.. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Eastman Kodak Company (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 Eastman Kodak Company devices

Submission Details

510(k) Number K801209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1980
Decision Date June 26, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 37
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K801209.
KODAK X-OMAT PROCESSOR, MODEL ME-3
K860666 · Eastman Kodak Company · Mar 1986
KODAK RP X-OMAT PROCESSOR MODEL M6B
K855219 · Eastman Kodak Company · Jan 1986
KODAK M35 X-OMAT PROCESSOR
K854219 · Eastman Kodak Company · Jan 1986
PROCESSOR, MODEL M8
K781934 · Eastman Kodak Company · Dec 1978
CRONEX QC-1 PROCESSOR
K780248 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1978
AUTOMIXER, KODAK
K771857 · Eastman Kodak Company · Oct 1977