Cleared Traditional

K900758 - HEPARINIZED ARTERIAL SCREEN BLOOD FILTER

K900758 is the FDA 510(k) clearance for HEPARINIZED ARTERIAL SCREEN BLOOD FILTER by Cobe Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K900758 · Cobe Laboratories, Inc. · Cardiovascular device
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May 1990
Decision
90d
Days
Class 2
Risk

K900758 is an FDA 510(k) clearance for the HEPARINIZED ARTERIAL SCREEN BLOOD FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on May 17, 1990 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 870.4260 - 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K900758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date May 17, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 25
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K900758.
MEDTRONIC ARTERIAL FILTER
K926413 · Medtronic Vascular · Aug 1993
GISH ARTERIAL FILTER
K914791 · Gish Biomedical, Inc. · Apr 1993
SHILEY PERFUSION TUBING SETS
K920594 · Shiley, Inc. · Mar 1993
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · Johnson & Johnson Professionals, Inc. · Jan 1987
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · Cobe Laboratories, Inc. · Feb 1986
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · Gish Biomedical, Inc. · Jul 1985