# K070189: Accu-Chek Ultraflex Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Disetronic Medical Systems AG
- Decided: Feb 21, 2007 after 30 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) current legally marketed version of the same device: named in the summary without a submission number

## Most influential descendants
- K101196: Accu-Chek Ultrflex Infusion Set (2010), 0 descendants of its own

## Indications for use
The ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

Source page: https://510kreport.com/device/K070189
Methodology: https://510kreport.com/methodology