Cleared Traditional

K122174 - PEDIATRIC POSITIONER PAD SET

K122174 is an FDA 510(k) clearance for PEDIATRIC POSITIONER PAD SET, manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). The device is a Class 1 Radiology device with product code KXH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K122174 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device
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Nov 2012
Decision
116d
Days
Class 1
Risk

K122174 is an FDA 510(k) clearance for the PEDIATRIC POSITIONER PAD SET. Classified as Cradle, Patient, Radiologic (product code KXH), Class I - General Controls.

Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on November 16, 2012 after a review of 116 days - within the typical 510(k) review window.

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 Ge Healthcare Coils (Usa Instruments, Inc.) devices

FDA 510(k) Submission Details - K122174

510(k) Number K122174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2012
Decision Date November 16, 2012
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
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.