# K823451: Clear Cardioplejia Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Jan 14, 1983 after 58 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 1, 2011 · Class II · Z-0158-2015: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
- Jun 8, 2010 · Not classified · Z-2161-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2157-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2162-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2154-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2159-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2158-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2155-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2153-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2151-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2152-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2156-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2149-2010: Vent port may be occluded and prevent delivery of fluid
- Jun 8, 2010 · Not classified · Z-2160-2010: Vent port may be occluded and prevent delivery of fluid

Source page: https://510kreport.com/device/K823451
Methodology: https://510kreport.com/methodology