Cleared Traditional

K220635 - Heater-Cooler System 3T

K220635 is an FDA 510(k) clearance for Heater-Cooler System 3T, manufactured by Livanova Deutschland, GmbH. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K220635 · Livanova Deutschland, GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
257d
Days
Class 2
Risk

K220635 is an FDA 510(k) clearance for the Heater-Cooler System 3T. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Livanova Deutschland, GmbH (Munchen, DE). The FDA issued a Cleared decision on November 16, 2022 after a review of 257 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 Livanova Deutschland, GmbH devices

FDA 510(k) Submission Details - K220635

510(k) Number K220635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2022
Decision Date November 16, 2022
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
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 11
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K220635.
Quantum Heater-Cooler
K212657 · Spectrum Medical , Ltd. · May 2022
Heater-Cooler System 3T
K191402 · Livanova Deutschland, GmbH · Feb 2020
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