Cleared Abbreviated

SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (K012763) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K012763 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
90d
Days
Class 2
Risk

K012763 is an FDA 510(k) clearance for the SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on November 15, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

Submission Details

510(k) Number K012763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2001
Decision Date November 15, 2001
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 69
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K012763.
TRANSMITTER, ZS-940PA SERIES
K043517 · Nihon Kohden America, Inc. · Feb 2005
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2004
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · Datascope Corp. · Jun 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · Nihon Kohden America, Inc. · Jan 1998
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194 · Hewlett-Packard Co. · Nov 1992