Cleared Traditional

K930124 - VARIANT OF OCTOSTOP AND OCTOPAQUE

K930124 is an FDA 510(k) clearance for VARIANT OF OCTOSTOP AND 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 393-day FDA review.

K930124 · Octostop, Inc. · Radiology device
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Feb 1994
Decision
393d
Days
Class 1
Risk

K930124 is an FDA 510(k) clearance for the VARIANT OF OCTOSTOP AND 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 February 9, 1994 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K930124

510(k) Number K930124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date February 09, 1994
Days to Decision 393 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
286d slower than avg
Panel avg: 107d · This submission: 393d
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.