# K803277: Tygon Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Electromedics, Inc.
- Decided: Jan 13, 1981 after 15 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K964205: Better-Tubing (1998), 1 descendant of its own
- K041650: Micro Prime (2004), 0 descendants of its own

## Recalls of this device
- Nov 27, 2018 · Class II · Z-0785-2019: Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in 

Source page: https://510kreport.com/device/K803277
Methodology: https://510kreport.com/methodology