# K082590: Symphony Meter Remote

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Dec 17, 2008 after 100 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: 3 generations back to K950727 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080639: Symphony Glucose Management System, Animas Corp. (2008) Summary page 2.

## Indications for use
The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

Source page: https://510kreport.com/device/K082590
Methodology: https://510kreport.com/methodology