Cleared Traditional

K901253 - (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000

K901253 is an FDA 510(k) clearance for (PBS) PORTABLE BYPASS SYSTEM, manufactured by Bio Medicus, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K901253

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.

DTZ Device Classification - Class 2, Special Controls

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 237
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