Cleared Traditional

K014016 - ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

K014016 is an FDA 510(k) clearance for ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA..., manufactured by Minntech Corp.. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K014016 · Minntech Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
58d
Days
Class 2
Risk

K014016 is an FDA 510(k) clearance for the ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Minntech Corp. devices

FDA 510(k) Submission Details - K014016

510(k) Number K014016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2001
Decision Date February 01, 2002
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWC Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K014016.
HEATER-COOLER UNIT HCU 40
K130300 · Maquet Cardiopulmonary, AG · Jul 2013
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521 · Terumo Cardiovascular Systems Corp. · Nov 2007
STOCKERT HEATER-COOLER SYSTEM 3T
K052601 · Sorin Group Deutschland GmbH · Jun 2006
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
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927 · Pioneering Technologies, Inc. · Jan 1988