# K003551: Venous Hardshell Cardiotomy Resevoir, Model VHK 4201

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AG
- Decided: Jul 11, 2001 after 236 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has 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
- K061743: Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum Tight, Model BSQ-VHK 2001 (2006), 3 descendants of its own
- K090534: Venous Hardshell Cardiotomy Reserviors (2009), 2 descendants of its own
- K102919: Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe (2011), 1 descendant of its own
- K141432: Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K003551
Methodology: https://510kreport.com/methodology