Cleared Traditional

VECTOR BAR SUSPENSION/TRACTION UNIT (K852398) - FDA 510(k) Clearance

Class I Physical Medicine device.

K852398 · Powlan Manufacturing Co. · Physical Medicine device
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Aug 1985
Decision
67d
Days
Class 1
Risk

K852398 is an FDA 510(k) clearance for the VECTOR BAR SUSPENSION/TRACTION UNIT. Classified as Accessories, Traction (product code ILZ), Class I - General Controls.

Submitted by Powlan Manufacturing Co. (Lafayette, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5925 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Powlan Manufacturing Co. devices

Submission Details

510(k) Number K852398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date August 12, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILZ Accessories, Traction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5925
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.