Cleared Traditional

K854241 - AOT EXTERNAL COMPRESS DEVICE (FDA 510(k) Clearance)

Class I Orthopedic device.

K854241 · Advanced Ortho-Technology, Inc. · Orthopedic device
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Mar 1986
Decision
133d
Days
Class 1
Risk

K854241 is an FDA 510(k) clearance for the AOT EXTERNAL COMPRESS DEVICE. Classified as Instrument, Compression (product code HWN), Class I - General Controls.

Submitted by Advanced Ortho-Technology, Inc. (Tuckahoe, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Advanced Ortho-Technology, Inc. devices

Submission Details

510(k) Number K854241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date March 03, 1986
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWN Instrument, Compression
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.