Cleared Traditional

K892387 - MODIFIED GELMAN ARTERIAL FILTER

K892387 is the FDA 510(k) clearance for MODIFIED GELMAN ARTERIAL FILTER by Gelman Sciences, Inc.. It is a Class 2 Toxicology device (product code DTM) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K892387 · Gelman Sciences, Inc. · Toxicology device
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Jun 1989
Decision
69d
Days
Class 2
Risk

K892387 is an FDA 510(k) clearance for the MODIFIED GELMAN ARTERIAL FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 870.4260 - the FDA toxicology device 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 Gelman Sciences, Inc. devices

Submission Details

510(k) Number K892387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1989
Decision Date June 22, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 87d · This submission: 69d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 60
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K892387.
MODIFIED PYROGEN TESTING
K910935 · Electromedics, Inc. · May 1991
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723 · Electromedics, Inc. · Dec 1990
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
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
K862068 · Gelman Sciences, Inc. · Aug 1986
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · Cobe Laboratories, Inc. · Feb 1986