Cleared Traditional

K896778 - RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE

K896778 is an FDA 510(k) clearance for RMI VASOPLEGIA CANNULA WITH & WITHOUT C..., manufactured by Research Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896778 · Research Medical, Inc. · Cardiovascular device
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Feb 1990
Decision
88d
Days
Class 2
Risk

K896778 is an FDA 510(k) clearance for the RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 27, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K896778

510(k) Number K896778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date February 27, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 302
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K896778.
SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
K900753 · Shiley, Inc. · Apr 1990
PICSO CANNULA, CATALOG CODE 94315
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RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
K896777 · Research Medical, Inc. · Feb 1990
RMI ANTEPLEGIA CANNULA
K896636 · Research Medical, Inc. · Feb 1990
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1989
PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT
K894684 · Pioneering Technologies, Inc. · Oct 1989