Cleared Traditional

K904218 - SUCTION SYSTEM

K904218 is an FDA 510(k) clearance for SUCTION SYSTEM, manufactured by Axiom Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K904218 · Axiom Medical, Inc. · General & Plastic Surgery device
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Oct 1990
Decision
49d
Days
Class 1
Risk

K904218 is an FDA 510(k) clearance for the SUCTION SYSTEM. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Paramount, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 49 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K904218

510(k) Number K904218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date October 31, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
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 11
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K904218.
ORIGIN SECONDARY CANNULA AND TROCAR
K922460 · Origin Medsystems, Inc. · Sep 1992
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
K920110 · Ethicon, Inc. · Apr 1992
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · United States Surgical, A Division of Tyco Healthc · Nov 1989
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · CooperVision, Inc. · Aug 1987
NEWMAN CANNULAE SYSTEM (NCS)
K862936 · Byron Medical · Aug 1986