Pivot Insulin Delivery System— 510(k) K262153

Name: FDA 510(k) clearance K262153
Creator: U.S. Food and Drug Administration
Published: 2026-09-02

Substantially Equivalent

Modular Medical, Inc.

FDA 510(k) clearance K262153 for Pivot Insulin Delivery System, Substantially Equivalent on 2026-09-02. Applicant: Modular Medical, Inc.. Device class: 2.

Clearance details

Applicant: Modular Medical, Inc.
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2026-06-26
Decision date: 2026-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZG

view all

K253534 — Pivot Insulin Delivery System2026-04-08
K240158 — Modular Medical MODD1 Insulin Delivery System2024-09-04
K241622 — Extended Reservoir; MiniMed Reservoir2024-07-02
K223372 — Omnipod GO Insulin Delivery Device2023-04-24
K210714 — Extended Reservoir2022-04-06

Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.