Cleared Traditional

K873038 - TECHTON PROTECTIVE PAD (FDA 510(k) Clearance)

Class I Radiology device.

K873038 · Techton, Inc. · Radiology device
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Apr 1989
Decision
608d
Days
Class 1
Risk

K873038 is an FDA 510(k) clearance for the TECHTON PROTECTIVE PAD. Classified as Curtain, Protective, Radiographic (product code IWQ), Class I - General Controls.

Submitted by Techton, Inc. (Albuquerque, US). The FDA issued a Cleared decision on April 3, 1989 after a review of 608 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Techton, Inc. devices

Submission Details

510(k) Number K873038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date April 03, 1989
Days to Decision 608 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
501d slower than avg
Panel avg: 107d · This submission: 608d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWQ Curtain, Protective, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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.