Cleared Traditional

K912082 - SAFE II

K912082 is the FDA 510(k) clearance for SAFE II by Polystan A/S. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K912082 · Polystan A/S · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
208d
Days
Class 2
Risk

K912082 is an FDA 510(k) clearance for the SAFE II. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Polystan A/S (Denmark, DK). The FDA issued a Cleared decision on December 4, 1991 after a review of 208 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 A/S devices

Submission Details

510(k) Number K912082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date December 04, 1991
Days to Decision 208 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
83d slower than avg
Panel avg: 125d · This submission: 208d
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 K912082.
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
K923272 · Cobe Laboratories, Inc. · May 1993
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K925626 · Medtronic Vascular · Feb 1993
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · Medtronic Vascular · Sep 1992
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
K912079 · 3M Health Care, Sarns · Oct 1991
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · 3M Health Care, Ltd. · Sep 1991
MINIMAX OXYGENATION SYSTEM
K912655 · Medtronic Vascular · Sep 1991