# K041849: Turbo-Flo Picc

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jul 21, 2005 after 378 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: 4 generations back to K001901 (2000). 7 ancestors in all.
8 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992198: Urethane Picc Line Model Upics-, Cook, Inc. (1999) Summary page 2.
- K010034: Double Lumen Urethane Picc Line, Model Upicds-, Cook, Inc. (2001) Summary page 2.
- K033389: Powerpicc Catheters, Models 3175155, 3175135, C.R. Bard, Inc. (2004) Summary page 2.

## Most influential descendants
- K082047: Securacath Catheter, Model SPK01 (2008), 6 descendants of its own
- K083081: Modification to Securacath, Model: SPK01 (2009), 5 descendants of its own
- K092306: Securacath Universal (2010), 4 descendants of its own
- K120935: Securacath (2012), 3 descendants of its own
- K180769: SecurAcath (2018), 2 descendants of its own

## Indications for use
Turbo-Flo® Peripherally Inserted Central Venous Catheters (PICC) are indicated for short or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The maximum pressure setting/limit of power injectors used with the Turbo-Flo PICC may not exceed 300 psi for the 5 Fr single lumen and 200 psi for the 4 Fr single lumen and 5 Fr double lumen. The Turbo-Flo PICC is indicated for a single injection of contrast media through a power injection.

Source page: https://510kreport.com/device/K041849
Methodology: https://510kreport.com/methodology