Cleared Traditional

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

Class I General & Plastic Surgery device.

K920471 · Lifeguard Medical Products, Inc. · General & Plastic Surgery device
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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
32d slower than avg
Panel avg: 115d · 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.

Regulatory Peers - GAD Retractor

All 14
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K920471.
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984