# K070844: Nilimedix Adi

- Pathway: 510(k) (Traditional)
- Applicant: Nilimedix, Ltd.
- Decided: Jun 6, 2008 after 437 days
- Product code: LZG (Pump, Infusion, Insulin)
- 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: 1 generation back to K990801 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990801: Minimed 508 Insulin Pump, Medtronic Minimed (1999) Summary page 1.

## Indications for use
The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K070844
Methodology: https://510kreport.com/methodology