Cleared Traditional

K893704 - SAFE-1

K893704 is the FDA 510(k) clearance for SAFE-1 by Polystan C/O Vitalcor, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K893704 · Polystan C/O Vitalcor, Inc. · Cardiovascular device
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Dec 1989
Decision
218d
Days
Class 2
Risk

K893704 is an FDA 510(k) clearance for the SAFE-1. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Polystan C/O Vitalcor, Inc. (Denmark, DK). The FDA issued a Cleared decision on December 22, 1989 after a review of 218 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Polystan C/O Vitalcor, Inc. devices

Submission Details

510(k) Number K893704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1989
Decision Date December 22, 1989
Days to Decision 218 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 125d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 196
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K893704.
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
K894826 · Bentley Laboratories, Inc. · Feb 1990
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SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
K896671 · 3M Company · Feb 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · 3M Company · Dec 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · 3M Company · Dec 1989
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K894970 · Minntech Corp. · Nov 1989