# K190855: BD Acute Central Line

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc. (Bard Has Joined Bd)
- Decided: Nov 1, 2019 after 213 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 24 ancestors in all.
3 later devices descend from it; 3 cite it directly.
4 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter, Arrow International, Inc. (2007) Summary page 4.

## Most influential descendants
- K242429: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System (2025), 0 descendants of its own
- K221827: Mais Central Venous Catheter (2023), 0 descendants of its own
- K200266: BD Centro Vena Acute Central Line (7 French Dual Lumen) (2020), 0 descendants of its own

## Indications for use
Acute central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

Source page: https://510kreport.com/device/K190855
Methodology: https://510kreport.com/methodology