# K100567: Pearl Diabetes Management System

- Pathway: 510(k) (Traditional)
- Applicant: M2 Group Holdings, Inc.
- Decided: May 10, 2011 after 435 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: 6 generations back to K905693 (1991). 7 ancestors in all.
2 later devices descend 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)
- K994186: Disetronic D-Tron Insulin Infusion Pump, Disetronic Medical Systems (1999) Summary page 1.
- K043000: Modification to D-Tronplus, Disetronic Medical Systems AG (2004) Summary page 1.
- K032257: Model IR 1200 Insulin Pump, Animas Corp. (2003) Summary page 1.

## Most influential descendants
- K122483: Pearl Diabetes Management System (2013), 1 descendant of its own
- K142619: Snap Insulin Pump System (2014), 0 descendants of its own

## Indications for use
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/K100567
Methodology: https://510kreport.com/methodology