# K262153: Pivot Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Modular Medical, Inc.
- Decided: Sep 2, 2026 after 68 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: 11 generations back to K901588 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253534: Pivot Insulin Delivery System, Modular Medical (2026) Summary page 5.

## Indications for use
The Pivot Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

Source page: https://510kreport.com/device/K262153
Methodology: https://510kreport.com/methodology