# K213004: Needle Free Connector

- Pathway: 510(k) (Traditional)
- Applicant: Medcaptain Life Science Co., Ltd.
- Decided: May 10, 2022 after 232 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: 1 generation back to K970855 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 4.

## Indications for use
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.

Source page: https://510kreport.com/device/K213004
Methodology: https://510kreport.com/methodology