# K143446: Accu-Chek FlexLink Plus infusion set

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics GmbH
- Decided: Aug 13, 2015 after 254 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 K100704 (2010). 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)
- K100704: Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion Device, Disetronic Medical Systems AG (2010) Summary page 4.

## Indications for use
ACCU-CHEK FlexLink Plus is an infusion set for the subcutaneous infusion of insulin.

Source page: https://510kreport.com/device/K143446
Methodology: https://510kreport.com/methodology