# K093065: Finesse Personal Insulin Delivery Patch, Model FG-2000

- Pathway: 510(k) (Traditional)
- Applicant: Calibra Medical, Inc.
- Decided: Jan 20, 2010 after 112 days
- Product code: OPP (Pump, Infusion, Insulin Bolus)
- 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: 2 generations back to K031373 (2003). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053563: Humapen Memoir, Eli Lilly and Company (2006) Summary page 2.
- K050971: Biovalve Insulin Delivery Systems (Bids), Biovalve Technologies, Inc. (2005) Summary page 2.

## Most influential descendants
- K100947: Finesse Personal Insulin Delivery Patch, Model FG 2000 (2010), 5 descendants of its own
- K111924: Finesse Personal Insulin Delivery Patch (2012), 4 descendants of its own
- K163357: OneTouch Via On-Demand Insulin Delivery System (2017), 3 descendants of its own
- K233447: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), 2 descendants of its own
- K243273: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), 1 descendant of its own

## Indications for use
The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K093065
Methodology: https://510kreport.com/methodology