# K050971: Biovalve Insulin Delivery Systems (Bids)

- Pathway: 510(k) (Traditional)
- Applicant: Biovalve Technologies, Inc.
- Decided: Aug 16, 2005 after 120 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: 1 generation back to K031373 (2003). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031373: Ixl Diabetes Management System, Insulet Corp. (2003) Summary page 1.

## Most influential descendants
- K093065: Finesse Personal Insulin Delivery Patch, Model FG-2000 (2010), 6 descendants of its own
- 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

## Indications for use
The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K050971
Methodology: https://510kreport.com/methodology