Cleared Traditional

K920471 - LEVY ARTICULATING RETRACTOR (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K920471 · Lifeguard Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
147d
Days
Class 1
Risk

K920471 is an FDA 510(k) clearance for the LEVY ARTICULATING RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Lifeguard Medical Products, Inc. (River Forest, US). The FDA issued a Cleared decision on June 23, 1992 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifeguard Medical Products, Inc. devices

Submission Details

510(k) Number K920471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1992
Decision Date June 23, 1992
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 114d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.