# K041152: Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A

- Pathway: 510(k) (Special)
- Applicant: Applied Diabetes Research, Inc.
- Decided: May 24, 2004 after 21 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K991936 (2000). 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)
- K024056: Sureset 3.0 ML Reservoir, Model 24-103, Applied Diabetes Research, Incorporated (2003) Summary page 1.

## Indications for use
The ThinSet Reservoir is indicated for use for the infusion of medicine, including insulin, from an insulin pump. The reservoir is not intended for use with blood or blood products.

Source page: https://510kreport.com/device/K041152
Methodology: https://510kreport.com/methodology