510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Cobe Heart/Lung Perfusion and Cardioplegia Pack

K881330510(k) TraditionalCleared Jun 10, 198873-day reviewClass II21 CFR 870.4210Recalls 41

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

Cobe Laboratories, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jun 10, 1988 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 41 times.

Decided
Jun 10, 1988
Review
73 days
Class
Class II
Product code
DWF
Recalls
41
Predicates
0

13 later devices descend from it, 2 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2005: 1 descendant cleared2009: 3 descendants cleared2008: 1 descendant cleared2006: 1 descendant cleared2014: 2 descendants cleared, 1 with a Class I recall12020: 1 descendant cleared, 1 with a Class I recall12011: 1 descendant cleared, 1 with a Class I recall12013: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK881330 Cobe Heart/Lung Perfusion and Cardioplegia PackCobe Laboratories, Inc. · 1988
  2. Descendant · cites it directly · 12 of its ownK053025 Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK090533 HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009
  5. Descendant · 3 generations on · 2 of its ownK200109 OXY-1 SystemAbiomed, Inc. · 2020 · Recalled (Class I)
  6. Descendant · 3 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 12009: 32011: 12013: 12014: 22020: 12022: 12023: 1
2005high 3 (2009) · low 0 (2007)2026

Class I recalls in this family

  • K200109 OXY-1 System3 generations on · 2020
  • K102726 Cardiohelp System3 generations on · 2011
  • K133598 Cardiohelp System4 generations on · 2014

Most influential descendants

Showing 5 of 13 · See all
  • K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · cites it directly12descendants
  • K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · 2 generations on8descendants
  • K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG · 2009 · 3 generations on3descendants
  • K200109OXY-1 SystemAbiomed, Inc. · 2020 · 3 generations on2descendants
  • K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881330Cobe Heart/Lung Perfusion and Cardioplegia PackCobe Laboratories, Inc.1988—
+1K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG20052
+2K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG2008221
+3K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG2009—
+3K200109OXY-1 SystemAbiomed, Inc.2020Class I
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG2011Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200810
200930
201111
201310
201421
202011
202210
202310
FIG. 1 — Lineage of K881330, 1988–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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 DWF device

  1. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG200512
K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc.20091

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 9, 2018Class IIZ-0770-2019Process control4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.
Jan 19, 2016Class IIIZ-1018-2016Component design/selectionThe CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not…
Jul 8, 2013Class IIZ-1985-2013Material/Component ContaminationSorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
Oct 7, 2010Not classifiedZ-0371-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0370-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0374-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0375-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0377-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0379-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0380-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0382-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0383-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0384-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0385-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0387-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0388-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0391-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0372-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0373-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0376-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0378-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0381-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0386-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0389-2011Packaging process controlDefective product packaging may compromise product sterility.
Oct 7, 2010Not classifiedZ-0390-2011Packaging process controlDefective product packaging may compromise product sterility.
Dec 30, 2009Not classifiedZ-1098-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1094-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1086-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1093-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1092-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1097-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1096-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1084-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1099-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1085-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1090-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1095-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1089-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1087-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1088-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Dec 30, 2009Not classifiedZ-1091-2010Packaging process controlTubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

The 5 latest of 41 recalls; the web page lists all.

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 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
  • 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, K053025 (Maquet Cardiopulmonary, AG, 2005) has gone furthest, with 12 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

More from Cobe Laboratories, Inc.

77 FDA decisions under this applicant name. See the company

  • K923272Cobe CMS-HF Hollow Fiber Membrane OxygenatorCobe Laboratories, Inc. · 1993
  • K900105Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
  • K905793Cobe Centry 2 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K905388Cobe Centrysystem 3 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K904336New Cobe Saturation/Hematocrit MonitorCobe Laboratories, Inc. · 1990

Recent decisions in DWF

The DWF category page

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K881330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881330: Cobe Heart/Lung Perfusion and Cardioplegia Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881330

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026