Cleared Traditional

K901231 - RMI CARDIOPLEGIA DELIVERY KITS

K901231 is an FDA 510(k) clearance for RMI CARDIOPLEGIA DELIVERY KITS, 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 86-day FDA review.

K901231 · Research Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
86d
Days
Class 2
Risk

K901231 is an FDA 510(k) clearance for the RMI CARDIOPLEGIA DELIVERY KITS. 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 June 8, 1990 after a review of 86 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 - K901231

510(k) Number K901231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date June 08, 1990
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K901231.
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · Fresenius USA, Inc. · Sep 1990
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · C.R. Bard, Inc. · Aug 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · Dlp, Inc. · Jul 1990
SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
K900753 · Shiley, Inc. · Apr 1990
PICSO CANNULA, CATALOG CODE 94315
K897022 · Dlp, Inc. · Mar 1990
RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
K896777 · Research Medical, Inc. · Feb 1990