Cleared Traditional

K980762 - PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE

K980762 is an FDA 510(k) clearance for PALL STAT-PRIME D BLOOD FILTER FOR EXTR..., manufactured by Pall Corp.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K980762 · Pall Corp. · Cardiovascular device
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Sep 1998
Decision
186d
Days
Class 2
Risk

K980762 is an FDA 510(k) clearance for the PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Pall Corp. (East Hills, US). The FDA issued a Cleared decision on September 1, 1998 after a review of 186 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 Pall Corp. devices

FDA 510(k) Submission Details - K980762

510(k) Number K980762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1998
Decision Date September 01, 1998
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
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 83
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K980762.
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379 · Medtronic Vascular · Feb 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
K994208 · Medtronic Perfusion Systems · Jan 2000
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254 · Cobe Cardiovascular, Inc. · 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