Cleared Traditional

K953976 - SAFE MICRO

K953976 is the FDA 510(k) clearance for SAFE MICRO by Polystan A/S. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 531-day FDA review.

K953976 · Polystan A/S · Cardiovascular device
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Feb 1997
Decision
531d
Days
Class 2
Risk

K953976 is an FDA 510(k) clearance for the SAFE MICRO. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Polystan A/S (Vaerlose, DK). The FDA issued a Cleared decision on February 4, 1997 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Polystan A/S devices

Submission Details

510(k) Number K953976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1995
Decision Date February 04, 1997
Days to Decision 531 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
406d slower than avg
Panel avg: 125d · This submission: 531d
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 192
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K953976.
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
K964043 · Cobe Cardiovascular, Inc. · Sep 1997
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
K961734 · Terumo Medical Corp. · Jul 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
K970463 · Terumo Medical Corp. · May 1997
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
K962641 · Medtronic Vascular · Dec 1996
GISH RELIANCE OXYGENATOR (MODEL HFO)
K961530 · Gish Biomedical, Inc. · Dec 1996
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
K954850 · C.R. Bard, Inc. · Oct 1996