# K161496: Turbo-Flo PICC Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 7, 2016 after 128 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001901 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041849: Turbo-Flo Picc, Cook, Inc. (2005) Summary page 5.

## Indications for use
Turbo-Flo Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids.

Source page: https://510kreport.com/device/K161496
Methodology: https://510kreport.com/methodology