# K122686: Accu-Chek Ultraflex Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Roche Diabetes Care AG
- Decided: Nov 16, 2012 after 73 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.
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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K091196: GRS Glenoid Resurfacing System, Arthrosurface, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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/K122686
Methodology: https://510kreport.com/methodology