# K241058: Lyka® PORT Needle Free Access Device (4170Y)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Dec 18, 2024 after 244 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 K040710 (2004). 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)
- K040710: Tego Needle Free Access Access Device, Icu Medical, Inc. (2004) Summary page 5.

## Indications for use
Lyka® PORT needle free access device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an |.V. Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The device may be used for patient populations including very low birth-weight infants, infants, children, and adults for up to 7 days.

Source page: https://510kreport.com/device/K241058
Methodology: https://510kreport.com/methodology