Cleared Traditional

K854005 - DEDO SUCTION CANNULA

K854005 is an FDA 510(k) clearance for DEDO SUCTION CANNULA, manufactured by Dedo Manufacturer, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K854005 · Dedo Manufacturer, Inc. · General & Plastic Surgery device
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Dec 1985
Decision
67d
Days
Class 1
Risk

K854005 is an FDA 510(k) clearance for the DEDO SUCTION CANNULA. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Dedo Manufacturer, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on December 6, 1985 after a review of 67 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 Dedo Manufacturer, Inc. devices

FDA 510(k) Submission Details - K854005

510(k) Number K854005 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 30, 1985
Decision Date December 06, 1985
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

GEA Device Classification - Class 1, General Controls

Product Code GEA Cannula, Surgical, General & Plastic Surgery
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 - GEA Cannula, Surgical, General & Plastic Surgery

All 18
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K854005.
DISPOSABLE SUCTION CANNULA NO. 902008-000
K863293 · Lifestream Int'L, Inc. · Sep 1986
NEWMAN CANNULAE SYSTEM (NCS)
K862936 · Byron Medical · Aug 1986
SUCTION SYSTEM
K861306 · Axiom Medical, Inc. · Jun 1986
PHARMA-PLAST SUCTION SET TYPE YANKAUER
K843468 · Zimmar Consulting , Ltd. · Nov 1984
CANNULA
K843187 · Ethicon, Inc. · Oct 1984
PADGETT SUCTION CANNULA
K833717 · Advanced Biosearch Assn. · Dec 1983