# K831769: Various Cardiovascular Surgical Device

- Pathway: 510(k) (Traditional)
- Applicant: Research Industries Corp.
- Decided: Aug 12, 1983 after 72 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 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
- K974259: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae (1998), 3 descendants of its own
- K123370: EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion Cannula (2013), 1 descendant of its own
- K091542: Estech Easyflow Cannula with Guidewire (2009), 1 descendant of its own
- K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (2025), 0 descendants of its own
- K233895: EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); (2024), 0 descendants of its own

## Recalls of this device
- Jul 14, 2008 · Not classified · Z-2401-2008: Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
- Jul 14, 2008 · Not classified · Z-2402-2008: Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
- Jul 14, 2008 · Not classified · Z-2403-2008: Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
- Apr 18, 2006 · Not classified · Z-1092-06: Due to potential embrittlement of the plastic tip which may crack or separate during use.
- Apr 18, 2006 · Not classified · Z-1091-06: Due to potential embrittlement of the plastic tip which may crack or separate during use.
- Apr 18, 2006 · Not classified · Z-1093-06: Due to potential embrittlement of the plastic tip which may crack or separate during use.
- Apr 18, 2006 · Not classified · Z-1090-06: Due to potential embrittlement of the plastic tip which may crack or separate during use.
- Apr 18, 2006 · Not classified · Z-1089-06: Due to potential embrittlement of the plastic tip which may crack or separate during use.

Source page: https://510kreport.com/device/K831769
Methodology: https://510kreport.com/methodology