Cleared Traditional

K904127 - A2J TELEMETER (FDA 510(k) Clearance)

Class I Radiology device.

K904127 · A2j, Inc. · Radiology device
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Jan 1991
Decision
128d
Days
Class 1
Risk

K904127 is an FDA 510(k) clearance for the A2J TELEMETER. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by A2j, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - 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 A2j, Inc. devices

Submission Details

510(k) Number K904127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date January 04, 1991
Days to Decision 128 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
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.