Pivot Insulin Delivery System— 510(k) K262153
Substantially EquivalentModular 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.
Summary
Pivot Insulin Delivery System comes from Modular Medical, Inc. under product code LZG (Pump, Infusion, Insulin). The record has nothing on the system beyond its name and code.
Class II, 21 CFR 880.5725. The Clinical Chemistry review panel handled it as a Traditional 510(k), though the record lists General Hospital as the classification panel. The decision was Substantially Equivalent.
Modular Medical filed from San Diego, California. The decision came 68 calendar days after receipt (June 26 to September 2, 2026).
Clearance details
- Applicant
- Modular Medical, Inc.
- Product code
- Product code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LZG
view allAdverse 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, through . 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.