# K171979: Tubing Pack

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 27, 2017 after 119 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K800178 (1980). 9 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K171308: Tubing Pack, Medtronic, Inc. (2017) Summary page 5.

## Most influential descendants
- 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
- Apr 29, 2021 · Class II · Z-1893-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1872-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1882-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1886-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1890-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1888-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1880-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1881-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1874-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1895-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1873-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1875-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1871-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1879-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1887-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1878-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1876-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1889-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1884-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1883-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1891-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1892-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1894-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1877-2021: Specific lots may have been manufactured with insufficient or incomplete welds.
- Apr 29, 2021 · Class II · Z-1885-2021: Specific lots may have been manufactured with insufficient or incomplete welds.

## 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/K171979
Methodology: https://510kreport.com/methodology