Cleared Traditional

K813034 - POLYSTAN HEART LUNG MACHINE SYS

K813034 is the FDA 510(k) clearance for POLYSTAN HEART LUNG MACHINE SYS by Advocacy International, Ltd.. It is a Class 2 Cardiovascular device (product code DTQ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K813034 · Advocacy International, Ltd. · Cardiovascular device
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Nov 1981
Decision
30d
Days
Class 2
Risk

K813034 is an FDA 510(k) clearance for the POLYSTAN HEART LUNG MACHINE SYS. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Advocacy International, Ltd. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Advocacy International, Ltd. devices

Submission Details

510(k) Number K813034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date November 27, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 23
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