Cleared Traditional

K890445 - PERSONAL ALERT ASSIST DEVICE

K890445 is an FDA 510(k) clearance for PERSONAL ALERT ASSIST DEVICE, manufactured by Silent Call Corp.. The device is a Class 1 Orthopedic device with product code LXI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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

FDA 510(k) Submission Details - K890445

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.

LXI Device Classification - Class 1, General Controls

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.