# K040710: Tego Needle Free Access Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Aug 11, 2004 after 146 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CLC 2000: named in the summary without a submission number
- (no number) Ultra-Site Valve: named in the summary without a submission number

## Most influential descendants
- K241058: Lyka® PORT Needle Free Access Device (4170Y) (2024), 0 descendants of its own

## Indications for use
The TEGO 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 Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The TEGO is a needle-free capping device which close the end of the catheter. The TEGO will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K040710
Methodology: https://510kreport.com/methodology