Cleared Traditional

K930357 - ACCESSORY TO UNIVERSAL OCTOPAQUE

K930357 is an FDA 510(k) clearance for ACCESSORY TO UNIVERSAL OCTOPAQUE, manufactured by Octostop, Inc.. The device is a Class 1 Radiology device with product code KXH cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

FDA 510(k) Submission Details - K930357

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.

KXH Device Classification - Class 1, General Controls

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.