Cleared Traditional

K102147 - CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

K102147 is an FDA 510(k) clearance for CARDIOQUIP MODULAR COOLER-HEATER MODEL ..., manufactured by Cardioquip Llp. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K102147 · Cardioquip Llp · Cardiovascular device
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Nov 2010
Decision
112d
Days
Class 2
Risk

K102147 is an FDA 510(k) clearance for the CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Cardioquip Llp (Bryan, US). The FDA issued a Cleared decision on November 19, 2010 after a review of 112 days - within the typical 510(k) review window.

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 Cardioquip Llp devices

FDA 510(k) Submission Details - K102147

510(k) Number K102147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date November 19, 2010
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 15
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K102147.
Heater-Cooler System 3T
K191402 · Livanova Deutschland, GmbH · Feb 2020
SORIN FLEXTHERM
K140012 · Sorin Group Deutschland GmbH · Jan 2014
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
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002