Cleared Traditional

K853126 - BIO PACK MODEL 200

K853126 is the FDA 510(k) clearance for BIO PACK MODEL 200 by Bio Medicus, Inc.. It is a Class 2 Cardiovascular device (product code DWA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K853126 · Bio Medicus, Inc. · Cardiovascular device
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Oct 1985
Decision
78d
Days
Class 2
Risk

K853126 is an FDA 510(k) clearance for the BIO PACK MODEL 200. 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 October 11, 1985 after a review of 78 days - a notably fast clearance cycle.

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: 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 Bio Medicus, Inc. devices

Submission Details

510(k) Number K853126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1985
Decision Date October 11, 1985
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
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 K853126.
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