# K100704: Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion Device

- Pathway: 510(k) (Special)
- Applicant: Disetronic Medical Systems AG
- Decided: May 14, 2010 after 63 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 13 (0 Class I)
- 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) ACCU-CHEK® Ultraflex infusion set: named in the summary without a submission number
- (no number) ACCU-CHEK® LinkAssist insertion device: named in the summary without a submission number

## Most influential descendants
- K143446: Accu-Chek FlexLink Plus infusion set (2015), 0 descendants of its own

## Recalls of this device
- Feb 24, 2011 · Not classified · Z-1483-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1491-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1484-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1482-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1487-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1480-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1489-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1492-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1486-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1481-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1488-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1490-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.
- Feb 24, 2011 · Not classified · Z-1485-2011: There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels.

## Indications for use
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets.

Source page: https://510kreport.com/device/K100704
Methodology: https://510kreport.com/methodology