Cleared Traditional

K874405 - PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (FDA 510(k) Clearance)

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

K874405 · Pall Biomedical Products Co. · Cardiovascular device
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Dec 1987
Decision
63d
Days
Class 2
Risk

K874405 is an FDA 510(k) clearance for the PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE. Classified as Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (product code JOD), Class II - Special Controls.

Submitted by Pall Biomedical Products Co. (Glen Cove, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4270 - 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 Pall Biomedical Products Co. devices

Submission Details

510(k) Number K874405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date December 30, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4270
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.