# K033099: Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109

- Pathway: 510(k) (Special)
- Applicant: Applied Diabetes Research, Incorporated
- Decided: Oct 16, 2003 after 17 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: 2 generations back to K991979 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012429: Sureset Infusion Set, Model 8023, Applied Diabetes Research, Incorporated (2001)

## Indications for use
The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

Source page: https://510kreport.com/device/K033099
Methodology: https://510kreport.com/methodology