Cleared Traditional

K901253 - (PBS) PORTABLE BYPASS SYSTEM

K901253 is the FDA 510(k) clearance for (PBS) PORTABLE BYPASS SYSTEM by Bio Medicus, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K901253 · Bio Medicus, Inc. · Cardiovascular device
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Sep 1990
Decision
173d
Days
Class 2
Risk

K901253 is an FDA 510(k) clearance for the (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 173 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 K901253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1990
Decision Date September 05, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 193
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K901253.
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
K911227 · 3M Health Care, Sarns · May 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · Baxter Healthcare Corp · Apr 1991
SARNS MEMBRANE OXGENATOR PART NUMBER 9443
K903436 · 3M Health Care, Sarns · Oct 1990
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901624 · Shiley, Inc. · Jul 1990
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K901249 · Shiley, Inc. · Jun 1990
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901250 · Shiley, Inc. · Jun 1990