# K850385: Intracardiac Sump 12010

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Apr 29, 1985 after 87 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1797-2024: Potential for unsealed sterile packing.
- Sep 29, 2008 · Not classified · Z-0609-2009: Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no a

Source page: https://510kreport.com/device/K850385
Methodology: https://510kreport.com/methodology