# K193158: ACENT™ Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Global Medikit Limited
- Decided: Nov 24, 2020 after 376 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: 3 generations back to K900263 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070451: Able Central Venous Catheter, Foshan Nanhai Bai HE Medical Technology Co., Ltd. (2007) Summary page 4.

## Indications for use
ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements. - for short-term (less than 30 days) infusion therapy or parenteral nutrition - for continuous or intermittent monitoring of the central venous pressure, - for blood sampling.

Source page: https://510kreport.com/device/K193158
Methodology: https://510kreport.com/methodology