# K230528: Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Medcaptain Life Science Co., Ltd.
- Decided: Dec 1, 2023 after 277 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942988 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153293: Extension Set, B.Braun Medical, Inc. (2016) Summary page 5.

## Indications for use
Extension Sets are intended to be used with a vascular access device for direct injection, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

Source page: https://510kreport.com/device/K230528
Methodology: https://510kreport.com/methodology