# K033892: Ultraflex Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems AG
- Decided: Mar 9, 2004 after 84 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 12 (0 Class I)
- 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 FDA summary names no predicate by number.

## Recalls of this device
- Mar 31, 2006 · Not classified · Z-1121-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1127-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1122-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1120-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1123-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1117-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1119-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1116-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1126-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1118-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Mar 31, 2006 · Not classified · Z-1124-06: The luer tube may break at the connection to the pump and, if this is not noticed by the patient, the patient may receive an under delivery of insulin.
- Mar 31, 2006 · Not classified · Z-1125-06: The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

## Indications for use
UltraflexTM is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

Source page: https://510kreport.com/device/K033892
Methodology: https://510kreport.com/methodology