# K012429: Sureset Infusion Set, Model 8023

- Pathway: 510(k) (Traditional)
- Applicant: Applied Diabetes Research, Incorporated
- Decided: Nov 6, 2001 after 98 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: 1 generation back to K991979 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991979: Sof-Set Micro QR Infusion Set, Models 320 and 321, Medtronic Minimed (1999) Summary page 1.

## Most influential descendants
- K033099: Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109 (2003), 0 descendants of its own

## Indications for use
Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump

Source page: https://510kreport.com/device/K012429
Methodology: https://510kreport.com/methodology