Cleared Traditional

K853947 - OMNI-TRACT CHEST WALL & LUNA RETRACTOR

K853947 is an FDA 510(k) clearance for OMNI-TRACT CHEST WALL & LUNA RETRACTOR, manufactured by Minnesota Scientific, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K853947 · Minnesota Scientific, Inc. · General & Plastic Surgery device
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Oct 1985
Decision
22d
Days
Class 1
Risk

K853947 is an FDA 510(k) clearance for the OMNI-TRACT CHEST WALL & LUNA RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Minnesota Scientific, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 22 days - a notably fast clearance cycle.

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: 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 Minnesota Scientific, Inc. devices

FDA 510(k) Submission Details - K853947

510(k) Number K853947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date October 16, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
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 62
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K853947.
ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000
K874243 · Pilling Co. · Nov 1987
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
RAYLOR(TM) PROTECTIVE RETRACTOR
K864424 · Cedar Surgical, Inc. · Nov 1986
RAYLOR RETRACTORS
K853796 · Cedar Surgical, Inc. · Oct 1985
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
K852530 · The Huxley Instrument Corp. · Jun 1985