Cleared Traditional

K191402 - Heater-Cooler System 3T

K191402 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 277-day FDA review.

K191402 · Livanova Deutschland, GmbH · Cardiovascular device
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Feb 2020
Decision
277d
Days
Class 2
Risk

K191402 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 (Munich, DE). The FDA issued a Cleared decision on February 25, 2020 after a review of 277 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 - K191402

510(k) Number K191402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2019
Decision Date February 25, 2020
Days to Decision 277 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
152d slower than avg
Panel avg: 125d · This submission: 277d
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 Consultant

LivaNova USA, Inc.
Scott Light

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K191402.
Heater-Cooler System 3T
K220635 · Livanova Deutschland, GmbH · Nov 2022
Quantum Heater-Cooler
K212657 · Spectrum Medical , Ltd. · May 2022
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