Cleared Traditional

POLYSTAN HEART-LUNG MACHINE SYSTEM (K894657) - FDA 510(k) Clearance

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

K894657 · Polystan C/O Vitalcor, Inc. · Toxicology device
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Mar 1990
Decision
247d
Days
Class 2
Risk

K894657 is an FDA 510(k) clearance for the POLYSTAN HEART-LUNG MACHINE SYSTEM. Classified as Test Reagents For Phenothiazine (product code DJQ), Class II - Special Controls.

Submitted by Polystan C/O Vitalcor, Inc. (Denmark, DK). The FDA issued a Cleared decision on March 28, 1990 after a review of 247 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3670 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Polystan C/O Vitalcor, Inc. devices

Submission Details

510(k) Number K894657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date March 28, 1990
Days to Decision 247 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 87d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJQ Test Reagents For Phenothiazine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3670
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 Toxicology devices follow this clearance model.