Cleared Traditional

K890445 - PERSONAL ALERT ASSIST DEVICE (FDA 510(k) Clearance)

Class I Orthopedic device.

K890445 · Silent Call Corp. · Orthopedic device
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May 1989
Decision
112d
Days
Class 1
Risk

K890445 is an FDA 510(k) clearance for the PERSONAL ALERT ASSIST DEVICE. Classified as Guide, Drill, Ligament (product code LXI), Class I - General Controls.

Submitted by Silent Call Corp. (Clarkston, US). The FDA issued a Cleared decision on May 19, 1989 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Silent Call Corp. devices

Submission Details

510(k) Number K890445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date May 19, 1989
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXI Guide, Drill, Ligament
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.