Cleared Abbreviated

K050111 - SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

K050111 is an FDA 510(k) clearance for SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG, manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Abbreviated 510(k) pathway after a 49-day FDA review.

K050111 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
49d
Days
Class 2
Risk

K050111 is an FDA 510(k) clearance for the SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on March 8, 2005 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K050111

510(k) Number K050111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date March 08, 2005
Days to Decision 49 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Standards-based clearance path.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K050111.
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527 · Sorin Group Italia S.R.L. · Jun 2006
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K051606 · Gish Biomedical, Inc. · Aug 2005
V-BAG WITH GBS COATING
K050195 · Gish Biomedical, Inc. · Mar 2005
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · Terumo Cardiovascular Systems Corp. · Mar 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · Terumo Cardiovascular Systems Corporation · Feb 2004
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · Cobe Cardiovascular, Inc. · Dec 2003