Pivot Insulin Delivery System— 510(k) K253534
Substantially EquivalentModular Medical
FDA 510(k) clearance K253534 for Pivot Insulin Delivery System, Substantially Equivalent on 2026-04-08. Applicant: Modular Medical. Device class: 2.
Summary
The Pivot Insulin Delivery System is an insulin pump from Modular Medical, filed under LZG, insulin infusion pumps. The record doesn't describe the pump further.
Class II, 21 CFR 880.5725, filed as a Traditional 510(k). The record lists General Hospital as the advisory panel and Clinical Chemistry as the review panel.
Modular Medical filed from San Diego, California. Review took 146 days (November 13, 2025 to April 8, 2026).
Clearance details
- Applicant
- Modular Medical
- 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.