510(k) · Cleared

Cleared

Cobe Century Perfusion Pump

K960974510(k) TraditionalCleared Jul 14, 1997490-day reviewClass II21 CFR 870.4370

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

Cobe Cardiovascular, Inc. · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

Cleared on Jul 14, 1997 after a 490-day review. The FDA summary names its predicate without a number. 2 of the 11 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided: Jul 14, 1997
Review: 490 days
Class: Class II
Product code: DWB
Recalls: None
Predicates: 0

10 later devices descend from it, 3 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.

This deviceK960974 Cobe Century Perfusion PumpCobe Cardiovascular, Inc. · 1997
Descendant · cites it directly · 8 of its ownK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
Descendant · 2 generations on · 5 of its ownK090006 Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009
Descendant · 3 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK070213 Performer CBP SystemRand S.R.L. · 2007 · Recalled
Descendant · cites it directly · 0 of its ownK202125 Century Perfusion SystemCentury Hlm, LLC · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 2 (2011) · low 0 (2008)2026

Class I recalls in this family

K102726 Cardiohelp System3 generations on · 2011
K133598 Cardiohelp System4 generations on · 2014

Most influential descendants

Showing 5 of 10 · See all

K052555Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · cites it directly8descendants
K090006Lifebridge B2T, Model 7001Lifebridge Medizintechnik AG · 2009 · 2 generations on5descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on2descendants
K070213Performer CBP SystemRand S.R.L. · 2007 · cites it directly1descendant
K202125Century Perfusion SystemCentury Hlm, LLC · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960974	Cobe Century Perfusion Pump	Cobe Cardiovascular, Inc.	1997	—
+1	K052555	Medtronic Performer TM CPB, Model R51, PCPB	Rand S.R.L.	2006	1
+2	K090006	Lifebridge B2T, Model 7001	Lifebridge Medizintechnik AG	2009	—
+3	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+1	K070213	Performer CBP System	Rand S.R.L.	2007	1
+1	K202125	Century Perfusion System	Century Hlm, LLC	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2009	1	0
2010	1	0
2011	2	1
2013	1	0
2014	1	1
2015	1	0
2021	1	0

FIG. 1 — Lineage of K960974, 1997–2021Source: 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.

2 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	—	COBE Precision Blood Pump Named without a submission number			—

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K052555	Medtronic Performer TM CPB, Model R51, PCPB	Rand S.R.L.	2006	8
K070213	Performer CBP System	Rand S.R.L.	2007	1
K202125	Century Perfusion System	Century Hlm, LLC	2021	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

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.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K052555 (Rand S.R.L., 2006) has gone furthest, with 8 descendants of its own.

How does its category compare?

All DWB devices

DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWB

1in 2016

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWB

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

Recalls per year · DWB

2in 2011

2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DWB

1in 2025

2007high 361 (2017) · low 1 (2025)2025

MAUDE reports naming product code DWB, 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	—	0	11
2008	0	—	0	11
2009	0	—	0	5
2010	0	—	0	14
2011	1	—	2	11
2012	0	—	0	27
2013	1	—	0	47
2014	0	—	0	63
2015	0	—	0	122
2016	1	—	0	318
2017	0	—	0	361
2018	0	—	0	258
2019	0	—	0	155
2020	0	—	0	79
2021	0	—	0	58
2022	0	—	0	87
2023	0	—	0	49
2024	0	—	0	39
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The COBE Century™ Precision Blood Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960974 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960974: Cobe Century Perfusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960974

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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