510(k) · Cleared

Recalled · Class II · 2017

Jostra HLM Tubing Set

K053025510(k) TraditionalCleared Nov 10, 200514-day reviewClass II21 CFR 870.4390Recalls 2

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

Maquet Cardiopulmonary, AG · DWE Tubing, Pump, Cardiopulmonary Bypass

Cleared on Nov 10, 2005 as substantially equivalent to K833322 (Gish Biomedical, Inc., 1983) and 6 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1989. 3 of the 21 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 2 times.

Decided: Nov 10, 2005
Review: 14 days
Class: Class II
Product code: DWE
Recalls: 2
Predicates: 7

Its longest line of descent runs back 2 generations to K895753 (1989). 8 ancestors in all, the oldest K771692 (1977). 12 later devices descend from it, 3 citing it directly. 3 of the 21 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK895753 Brevet Disposable ConnectorsBrevet, Inc. · 1989
1 generation backK041697 Terumo Circuit ConnectorsTerumo Cardiovascular Systems Corporation · 2004
This deviceK053025 Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005
Descendant · cites it directly · 8 of its ownK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · Recalled
Descendant · 2 generations on · 3 of its ownK090533 HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009
Descendant · 2 generations on · 2 of its ownK200109 OXY-1 SystemAbiomed, Inc. · 2020 · Recalled (Class I)
Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK092486 Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 2009 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006high 3 (2009) · low 0 (2007)2026

Class I recalls in this family

K200109 OXY-1 System2 generations on · 2020
K102726 Cardiohelp System2 generations on · 2011
K133598 Cardiohelp System3 generations on · 2014

Most influential descendants

Showing 5 of 12 · See all

K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · cites it directly8descendants
K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009 · 2 generations on3descendants
K200109OXY-1 SystemAbiomed, Inc. · 2020 · 2 generations on2descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 2009 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K895753	Brevet Disposable Connectors	Brevet, Inc.	1989	—
−1	K041697	Terumo Circuit Connectors	Terumo Cardiovascular Systems Corporation	2004	—
0 (this device)	K053025	Jostra HLM Tubing Set	Maquet Cardiopulmonary, AG	2005	—
+1	K080592	HLM Tubing Set with Bioline Coating	Maquet Cardiopulmonary, AG	2008	221
+2	K090533	HLM Tubing Set with Softline Coating	Maquet Cardiopulmonary, AG	2009	—
+2	K200109	OXY-1 System	Abiomed, Inc.	2020	Class I
+2	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+1	K092486	Vortex Medical Angiovac Cardiopulmonary Bypass Circuit	Vortex Medical, Inc.	2009	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1977	1	0
1980	1	0
1983	1	0
1988	1	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	3	0
2011	1	1
2013	1	0
2014	2	1
2020	1	1
2022	1	0
2023	1	0

FIG. 1 — Lineage of K053025, 1989–2023Source: 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.

3 devices in this family have a Class I recall. 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 DWE device

#1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall

Get a 510(k) Report

What was it cleared against? (7)

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
*	K833322	Tubing Connectors EC-2XXX Series Summary page 1 …manifold, or fitting Predicate Devices: Tubing and Connectors: Gish Biomedical, Tubing Connectors - K833322 Cobe Cardiovascular, Tubing Sets - K771692 Terumo Cardiovascular…	Gish Biomedical, Inc.	1983	22
*	K771692	Tubing Sets Summary page 1 …Tubing and Connectors: Gish Biomedical, Tubing Connectors - K833322 Cobe Cardiovascular, Tubing Sets - K771692 Terumo Cardiovascular Systems, Pump Tubing - K013578…	Cobe Laboratories, Inc.	1977	—
*	K013578	Pump Tubing Summary page 1 …Cobe Cardiovascular, Tubing Sets - K771692 Terumo Cardiovascular Systems, Pump Tubing - K013578 Terumo Cardiovascular Systems, Circuit Connectors - K041697…	Terumo Cardiovascular Systems Corp.	2002	—
*	K041697	Terumo Circuit Connectors Summary page 1 …Pump Tubing - K013578 Terumo Cardiovascular Systems, Circuit Connectors - K041697 Tubing Sets: Cobe Cardiovascular, Cobe Heart-Lung Perfusion…	Terumo Cardiovascular Systems Corporation	2004	—
*	K881330	Cobe Heart/Lung Perfusion and Cardioplegia Pack Summary page 1 …Tubing Sets: Cobe Cardiovascular, Cobe Heart-Lung Perfusion and Cardioplegia Pack - K881330 Medtronic Perfusion Systems, Intersept Blood Tubing Packs - K8001…	Cobe Laboratories, Inc.	1988	41
*	K800178	Extracorp.'S Intersept Cus. Tubing PK. Summary page 1 …and Cardioplegia Pack - K881330 Medtronic Perfusion Systems, Intersept Blood Tubing Packs - K800178 Maquet Cardiopulmonary, Jostra MECC Set - K023132 Device Descrip…	Extracorporeal Medical Specialities, Inc.	1980	10
*	K023132	Jostra Mecc System Summary page 1 …pt Blood Tubing Packs - K800178 Maquet Cardiopulmonary, Jostra MECC Set - K023132 Device Description: The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterili…	Jostra AG	2002	—

Also cleared against K833322: 1 other device →

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080592	HLM Tubing Set with Bioline Coating	Maquet Cardiopulmonary, AG	2008	8
K092486	Vortex Medical Angiovac Cardiopulmonary Bypass Circuit	Vortex Medical, Inc.	2009	1
K061832	Jostra HLM Tubing Sets with Safeline Coating	Maquet Cardiopulmonary, AG	2006	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 22, 2017	Class II	Z-0490-2018	Incorrect or no expiration date	55 kits were distributed after their expiration date of September 2015.
Jul 13, 2010	Not classified	Z-2401-2010	Process control	The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K200109OXY-1 SystemAbiomed, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
3 of the 8 ancestors have a recall of any class.
Of its descendants, K080592 (Maquet Cardiopulmonary, AG, 2008) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K833322.

How does its category compare?

All DWE devices

DWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWE

1in 2024

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWE

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

Recalls per year · DWE

2in 2017

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DWE

80in 2025

2007high 286 (2023) · low 7 (2012)2025

MAUDE reports naming product code DWE, 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	0	—	2	10
2008	1	—	0	12
2009	1	—	1	17
2010	0	—	2	20
2011	0	—	2	9
2012	0	—	0	7
2013	0	—	0	21
2014	1	—	1	129
2015	1	—	0	133
2016	0	—	0	151
2017	0	—	2	131
2018	0	—	0	134
2019	0	—	0	82
2020	0	—	0	45
2021	0	—	0	41
2022	0	—	0	123
2023	0	—	0	286
2024	1	—	0	221
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053025: Jostra HLM Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053025

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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