# K141432: Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jul 7, 2014 after 38 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K922933 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102919: Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe, Maquet Cardiopulmonary, AG (2011) Summary page 1.

## Recalls of this device
- Oct 25, 2018 · Class I · Z-0436-2019: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or b
- Oct 25, 2018 · Class I · Z-0437-2019: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or b

## Indications for use
The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Source page: https://510kreport.com/device/K141432
Methodology: https://510kreport.com/methodology