Cleared Traditional

K920471 - LEVY ARTICULATING RETRACTOR

K920471 is an FDA 510(k) clearance for LEVY ARTICULATING RETRACTOR, manufactured by Lifeguard Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 147-day FDA review.

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

FDA 510(k) Submission Details - K920471

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.

GAD Device Classification - Class 1, General Controls

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 59
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K920471.
SCION SAPHENOUS VEIN HARVESTING SYSTEM
K963006 · Scion International, Inc. · Sep 1996
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · Thomasville Medical Assoc. · Feb 1994
THOROCOSCOPY SELF-RETAINING RETRACTOR
K926585 · T. Korossurgical Instruments Corp. · Aug 1993
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
SUREBREATH DOME, E-Z BREATHER
K915158 · Ipax, Inc. · Feb 1992
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K903969 · Karlin Technology, Inc. · Sep 1990