# K101806: Aidera Diasend System

- Pathway: 510(k) (Traditional)
- Applicant: Aidera AB
- Decided: Dec 7, 2010 after 162 days
- Product code: MRZ (Accessories, 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: 12 generations back to K864318 (1987). 40 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083221: Aidera Diasend, Aidera AB (2009) Summary page 1.
- K072698: Confidant 2.5, Confidant, Inc. (2007) Summary page 1.
- K032164: Diabetes Data Management System (DDMS), Model 7333, Medtronic Minimed (2003) Summary page 1.

## Most influential descendants
- K132618: Onetouch Reveal (2013), 0 descendants of its own
- K122361: T:Connect Data Management System (2013), 0 descendants of its own

## Indications for use
Aidera Diasend is indicated for use by individuals or healthcare professionials in the borne or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.

Source page: https://510kreport.com/device/K101806
Methodology: https://510kreport.com/methodology