Cleared Traditional

K932187 - PRONE POSITIONER (FDA 510(k) Clearance)

Class I Orthopedic device.

K932187 · Voss Medical Products · Orthopedic device
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Jun 1993
Decision
27d
Days
Class 1
Risk

K932187 is an FDA 510(k) clearance for the PRONE POSITIONER. Classified as Positioner, Socket (product code KIL), Class I - General Controls.

Submitted by Voss Medical Products (Washington, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 27 days - a notably fast clearance cycle.

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

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Submission Details

510(k) Number K932187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1993
Decision Date June 01, 1993
Days to Decision 27 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIL Positioner, Socket
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.