Cleared Traditional

VENOUS CANNULA TRAY (K813284) - FDA 510(k) Clearance

Class I Cardiovascular device.

K813284 · Cunningham Woodland, Inc. · Cardiovascular device
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Dec 1981
Decision
36d
Days
Class 1
Risk

K813284 is an FDA 510(k) clearance for the VENOUS CANNULA TRAY. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Cunningham Woodland, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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 Cunningham Woodland, Inc. devices

Submission Details

510(k) Number K813284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1981
Decision Date December 29, 1981
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 14
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K813284.
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · GE Medical Systems · Apr 1996
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979
AORTIC OCCLUDER #000390
K792088 · Edward Weck, Inc. · Oct 1979