Cleared Traditional

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 (K961869) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961869 · Sorin Biomedical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
89d
Days
Class 2
Risk

K961869 is an FDA 510(k) clearance for the DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Sorin Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on August 12, 1996 after a review of 89 days - a notably fast clearance 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: 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 Sorin Biomedical, Inc. devices

Submission Details

510(k) Number K961869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1996
Decision Date August 12, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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 20
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K961869.
CAPIOX ARTERIAL FILTER
K002026 · Terumo Medical Corp. · Sep 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
K001138 · Medtronic Vascular · Apr 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379 · Medtronic Vascular · Feb 2000
CAPIOX ARTERIAL FILTER
K943917 · Terumo Medical Corp. · Jul 1995
MEDTRONIC ARTERIAL FILTER
K926413 · Medtronic Vascular · Aug 1993
SHILEY PERFUSION TUBING SETS
K920594 · Shiley, Inc. · Mar 1993