Cleared Traditional

K945198 - DIDECO PEDIATRIC ARTERIAL FILTERS

K945198 is an FDA 510(k) clearance for DIDECO PEDIATRIC ARTERIAL FILTERS, manufactured by Sorin Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K945198 · Sorin Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
246d
Days
Class 2
Risk

K945198 is an FDA 510(k) clearance for the DIDECO PEDIATRIC ARTERIAL FILTERS. 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 June 27, 1995 after a review of 246 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 Sorin Biomedical, Inc. devices

FDA 510(k) Submission Details - K945198

510(k) Number K945198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1994
Decision Date June 27, 1995
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K945198.
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
K980762 · Pall Corp. · Sep 1998
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K961869 · Sorin Biomedical, Inc. · Aug 1996
CAPIOX ARTERIAL FILTER
K943917 · Terumo Medical Corp. · Jul 1995
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