Cleared Traditional

K812444 - RADIATION STERILIZATION FOR NEEDLE CNTR

K812444 is an FDA 510(k) clearance for RADIATION STERILIZATION FOR NEEDLE CNTR, manufactured by Devon Industries, Inc.. The device is a Class 1 Radiology device with product code GAB cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K812444

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

GAB Device Classification - Class 1, General Controls

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.