510(k) · Cleared

Cleared

Heater-Cooler Unit Hcu 40

K130300510(k) TraditionalCleared Jul 1, 2013144-day reviewClass II21 CFR 870.4250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maquet Cardiopulmonary, AG · DWC Controller, Temperature, Cardiopulmonary Bypass

Cleared on Jul 1, 2013 as substantially equivalent to K031544 (Jostra AB, 2003) after a 144-day review. Its family tree reaches back 2 generations to 1988.

Decided: Jul 1, 2013
Review: 144 days
Class: Class II
Product code: DWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K883603 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883603 Sarns Temp. Control and Monitor System (TCM II)3M Health Care, Sarns · 1988 · Recalled
1 generation backK031544 Heater Cooler Unit, Model Hcu 30Jostra AB · 2003 · Recalled
This deviceK130300 Heater-Cooler Unit Hcu 40Maquet Cardiopulmonary, AG · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883603	Sarns Temp. Control and Monitor System (TCM II)	3M Health Care, Sarns	1988	4
−1	K031544	Heater Cooler Unit, Model Hcu 30	Jostra AB	2003	4
0 (this device)	K130300	Heater-Cooler Unit Hcu 40	Maquet Cardiopulmonary, AG	2013	—

FIG. 1 — Lineage of K130300, 1988–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DWC device

#1 K220635 Heater-Cooler System 3Tscore 5.3 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K031544	Heater Cooler Unit, Model Hcu 30 Summary page 1 …DWC PREDICATE DEVCE INFORMATION: The Heater-Cooler Unit HCU 40 is substantially equivalent in function and intended use to the Heater-Cooler Unit HCU 30 (K03 1544). DEVICE DESCRIPTION AND INTENDED USE: The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulat…	Jostra AB	2003	4

Also cleared against K031544: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
2 of the 2 ancestors have a recall of any class.
2 other devices also cite its predicate K031544.

How does its category compare?

All DWC devices

DWC Controller, Temperature, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DWC

2in 2022

2007high 2 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWC

Too few DWC 510(k)s in any year since 2007 to give a median.

Recalls per year · DWC

5in 2023

2007high 5 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWC

670in 2025

2007high 928 (2023) · low 0 (2008)2025

MAUDE reports naming product code DWC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	3
2008	0	—	0	0
2009	0	—	0	2
2010	1	—	1	243
2011	0	—	0	281
2012	1	—	2	351
2013	1	—	0	244
2014	1	—	1	378
2015	0	—	1	575
2016	0	—	1	787
2017	0	—	1	716
2018	0	—	3	564
2019	0	—	0	697
2020	1	—	0	548
2021	0	—	5	622
2022	2	—	0	605
2023	0	—	5	928
2024	0	—	0	555
2025	0	—	0	670
2026	0	—	0	—

What is it indicated for?

The HCU 40 is intended to circulate water through heat exchange circuits to

warm or cool a patient during short duration cardiopulmonary bypass procedures

lasting 6 hours or less.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130300 · printed Nov 4, 2026

Cite this page

510(k) Report. “K130300: Heater-Cooler Unit Hcu 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130300

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026