Cleared Traditional

K812444 - RADIATION STERILIZATION FOR NEEDLE CNTR (FDA 510(k) Clearance)

Class I Radiology device.

K812444 · Devon Industries, Inc. · Radiology device
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Dec 1981
Decision
108d
Days
Class 1
Risk

K812444 is an FDA 510(k) clearance for the RADIATION STERILIZATION FOR NEEDLE CNTR. Classified as Needle, Suturing, Disposable (product code GAB), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4800 - 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 Devon Industries, Inc. devices

Submission Details

510(k) Number K812444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1981
Decision Date December 14, 1981
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAB Needle, Suturing, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.