Cleared Traditional

K902723 - ARTERIAL BLOOD FILTER ELECTRO. AIR* STA...

K902723 is the FDA 510(k) clearance for ARTERIAL BLOOD FILTER ELECTRO. AIR* STA... by Electromedics, Inc.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K902723 · Electromedics, Inc. · Cardiovascular device
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Dec 1990
Decision
177d
Days
Class 2
Risk

K902723 is an FDA 510(k) clearance for the ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 177 days - an extended review cycle.

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 Electromedics, Inc. devices

Submission Details

510(k) Number K902723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date December 13, 1990
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
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 29
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K902723.
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
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
K900758 · Cobe Laboratories, Inc. · May 1990
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