Cleared Traditional

K031544 - HEATER COOLER UNIT, MODEL HCU 30

K031544 is an FDA 510(k) clearance for HEATER COOLER UNIT, manufactured by Jostra AB. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K031544 · Jostra AB · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
83d
Days
Class 2
Risk

K031544 is an FDA 510(k) clearance for the HEATER COOLER UNIT, MODEL HCU 30. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Jostra AB (The Woodlands, US). The FDA issued a Cleared decision on August 7, 2003 after a review of 83 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 Jostra AB devices

FDA 510(k) Submission Details - K031544

510(k) Number K031544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2003
Decision Date August 07, 2003
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 16
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K031544.
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
K122813 · Cincinnati Sub-Zero Products, Inc. · Dec 2012
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
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