# K881330: Cobe Heart/Lung Perfusion and Cardioplegia Pack

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Laboratories, Inc.
- Decided: Jun 10, 1988 after 73 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 41 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053025: Jostra HLM Tubing Set (2005), 12 descendants of its own
- K080592: HLM Tubing Set with Bioline Coating (2008), 8 descendants of its own
- K090533: HLM Tubing Set with Softline Coating (2009), 3 descendants of its own
- K200109: OXY-1 System (2020), 2 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own

## Recalls of this device
- Nov 9, 2018 · Class II · Z-0770-2019: 4-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 
- Jan 19, 2016 · Class III · Z-1018-2016: The 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 v
- Jul 8, 2013 · Class II · Z-1985-2013: Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
- Oct 7, 2010 · Not classified · Z-0371-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0370-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0374-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0375-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0377-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0379-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0380-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0382-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0383-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0384-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0385-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0387-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0388-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0391-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0372-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0373-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0376-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0378-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0381-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0386-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0389-2011: Defective product packaging may compromise product sterility.
- Oct 7, 2010 · Not classified · Z-0390-2011: Defective product packaging may compromise product sterility.
- Dec 30, 2009 · Not classified · Z-1098-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1094-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1086-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1093-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1092-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1097-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1096-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1084-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1099-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1085-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1090-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1095-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1089-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1087-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1088-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Dec 30, 2009 · Not classified · Z-1091-2010: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

Source page: https://510kreport.com/device/K881330
Methodology: https://510kreport.com/methodology