# K122483: Pearl Diabetes Management System

- Pathway: 510(k) (Special)
- Applicant: Asante Solutions, Inc.
- Decided: Jan 3, 2013 after 142 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: 7 generations back to K905693 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100567: Pearl Diabetes Management System, M2 Group Holdings, Inc. (2011) Summary page 2.

## Most influential descendants
- K142619: Snap Insulin Pump System (2014), 0 descendants of its own

## Indications for use
The Pearl Diabetes Management System is indicated for the continuous subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.

Source page: https://510kreport.com/device/K122483
Methodology: https://510kreport.com/methodology