# K053106: Tego, Model D1000

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: Jan 10, 2006 after 67 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 19, 2025 · Class II · Z-1111-2026: Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from 
- Aug 24, 2016 · Class II · Z-0988-2017: ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.

## Indications for use
The TEGO'h 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' h is a needle-free capping device, which close the end of a catheter. The TEGO h 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/K053106
Methodology: https://510kreport.com/methodology