# K063146: Accu-Chek Linkassist

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems AG
- Decided: Nov 27, 2006 after 42 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945660 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970479: Minimed Sof-Serter Infusion Set Insertion System, Model 300, Medtronic Minimed (1997) Summary page 2.
- K992300: Quick-Serter, Model 395, Medtronic Minimed (1999) Summary page 2.

## Indications for use
The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.

Source page: https://510kreport.com/device/K063146
Methodology: https://510kreport.com/methodology