Cleared Traditional

K792145 - AUTOMATIC RETRACTOR HOLDERS

K792145 is an FDA 510(k) clearance for AUTOMATIC RETRACTOR HOLDERS, manufactured by Automated 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 43-day FDA review.

K792145 · Automated Medical Products, Inc. · General & Plastic Surgery device
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Dec 1979
Decision
43d
Days
Class 1
Risk

K792145 is an FDA 510(k) clearance for the AUTOMATIC RETRACTOR HOLDERS. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Automated Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1979 after a review of 43 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 Automated Medical Products, Inc. devices

FDA 510(k) Submission Details - K792145

510(k) Number K792145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1979
Decision Date December 05, 1979
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
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 K792145.
ETHICON RETRACTION TAPE
K801699 · Ethicon, Inc. · Sep 1980
EFFRON PAROTID RETRACTOR
K801759 · American V. Mueller · Aug 1980
DEEP BALFOUR BLADE FOR WILKINSON RETRACT
K801611 · Edward Weck, Inc. · Aug 1980
SPREADER
K781445 · Orthopedic Equipment Co., Inc. · Sep 1979
TISSURE RETRACTORS
K791122 · Xomed, Inc. · Jul 1979
ULTRASOUND IMAGING SYSTEM
K780993 · Boehringer Mannheim Corp. · Aug 1978