Cleared Traditional

K854133 - BIO MEDICUS BIO CONSOLE 540

K854133 is the FDA 510(k) clearance for BIO MEDICUS BIO CONSOLE 540 by Bio Medicus, Inc.. It is a Class 2 Cardiovascular device (product code DWA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K854133 · Bio Medicus, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
90d
Days
Class 2
Risk

K854133 is an FDA 510(k) clearance for the BIO MEDICUS BIO CONSOLE 540. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 8, 1986 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 870.4380 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio Medicus, Inc. devices

Submission Details

510(k) Number K854133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1985
Decision Date January 08, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
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
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K854133.
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007
BARD ISOFLOW BLOOD PUMP
K971421 · C.R. Bard, Inc. · May 1998
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739 · 3M Health Care, Sarns · Nov 1995
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · Gambro, Inc. · Aug 1984
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952 · Medtronic Vascular · Aug 1978