Cleared Traditional

K893940 - POLYSTAN HEATER-COOLER UNIT

K893940 is the FDA 510(k) clearance for POLYSTAN HEATER-COOLER UNIT by Polystan C/O Vitalcor, Inc.. It is a Class 2 Cardiovascular device (product code DWC) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K893940 · Polystan C/O Vitalcor, Inc. · Cardiovascular device
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Jan 1990
Decision
232d
Days
Class 2
Risk

K893940 is an FDA 510(k) clearance for the POLYSTAN HEATER-COOLER UNIT. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Polystan C/O Vitalcor, Inc. (Denmark, DK). The FDA issued a Cleared decision on January 18, 1990 after a review of 232 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4250 - 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 K893940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1989
Decision Date January 18, 1990
Days to Decision 232 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 125d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWC Controller, Temperature, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4250
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - DWC Controller, Temperature, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K893940.
HEATER-COOLER UNIT HCU 40
K130300 · Maquet Cardiopulmonary, AG · Jul 2013
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521 · Terumo Cardiovascular Systems Corp. · Nov 2007
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603 · 3M Health Care, Sarns · Nov 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924 · Buckman Co., Inc. · Feb 1988
SARNS WARMER, PART #164975 AND #164980
K873813 · 3M Health Care, Sarns · Nov 1987