Cleared Traditional

K930357 - ACCESSORY TO UNIVERSAL OCTOPAQUE (FDA 510(k) Clearance)

Class I Radiology device.

K930357 · Octostop, Inc. · Radiology device
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Jul 1993
Decision
168d
Days
Class 1
Risk

K930357 is an FDA 510(k) clearance for the ACCESSORY TO UNIVERSAL OCTOPAQUE. Classified as Cradle, Patient, Radiologic (product code KXH), Class I - General Controls.

Submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on July 13, 1993 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1830 - 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 Octostop, Inc. devices

Submission Details

510(k) Number K930357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date July 13, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXH Cradle, Patient, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1830
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.