# K102919: Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Mar 11, 2011 after 161 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K922933 (1992). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir, Terumo Corp. (2002) Summary page 1.
- K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir, Sorin Group Italia S.R.L. (2007) Summary page 1.
- K090534: Venous Hardshell Cardiotomy Reserviors, Maquet Cardiopulmonary, AG (2009) Summary page 1.

## Most influential descendants
- K141432: Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh (2014), 0 descendants of its own

## Recalls of this device
- May 18, 2023 · Class II · Z-1661-2023: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, 
- May 18, 2023 · Class II · Z-1642-2023: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both i

## 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/K102919
Methodology: https://510kreport.com/methodology