# K171308: Tubing Pack

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jun 2, 2017 after 30 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K800178 (1980). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151523: Uncoated Tubing and Connector Components, Medtronic, Inc. (2015) Summary page 5.

## Most influential descendants
- K171979: Tubing Pack (2017), 2 descendants of its own
- K260043: Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (2026), 0 descendants of its own
- K213540: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set (2022), 0 descendants of its own

## Recalls of this device
- Jan 3, 2018 · Class II · Z-0535-2018: Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

## Indications for use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Source page: https://510kreport.com/device/K171308
Methodology: https://510kreport.com/methodology