Cleared Traditional

K872919 - OMNI-TRACT CORRAL RETRACTOR

K872919 is an FDA 510(k) clearance for OMNI-TRACT CORRAL 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 15-day FDA review.

K872919 · Minnesota Scientific, Inc. · General & Plastic Surgery device
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Aug 1987
Decision
15d
Days
Class 1
Risk

K872919 is an FDA 510(k) clearance for the OMNI-TRACT CORRAL 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 August 11, 1987 after a review of 15 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 - K872919

510(k) Number K872919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date August 11, 1987
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 K872919.
SELF-RETAINING SOFT TISSUE RETRACTOR
K880813 · T. Korossurgical Instruments Corp. · Mar 1988
SUCTION RETRACTOR
K875289 · T. Korossurgical Instruments Corp. · Jan 1988
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