# K122091: Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jul 29, 2013 after 378 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895417 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro, Arrow Intl., Inc. (2000) Summary page 1.

## Most influential descendants
- K161504: Cook Turbo-Flo HD Acute Hemodialysis  Catheter Set/Tray (2017), 0 descendants of its own

## Indications for use
The Cook Turbo-Flo HD Acute Hemodialysis Catheter is intended for acute hemodialysis, apheresis and hemofiltration. It is intended for percutaneous insertion into the subclavian, jugular or femoral veins. The device is a short-term use catheter (less than 30 days).

Source page: https://510kreport.com/device/K122091
Methodology: https://510kreport.com/methodology