K253534
Substantially EquivalentPivot Insulin Delivery System
The Pivot Insulin Delivery System is an insulin pump — product code LZG covers portable infusion pumps, including insulin-specific systems. Modular Medical's Pivot is positioned as a simpler, lower-cost alternative to full-featured pumps from Insulet, Tandem, and Medtronic.
General Hospital panel, Traditional 510(k). LZG insulin pumps go through rigorous technical review — dose-accuracy testing, alarm logic, and interoperability requirements are standard gating items. Five-month clock is reasonable for a newer-entrant pump.
Modular Medical files from San Diego. Pump 510(k)s tend to take longer than the category average — this timeline is at the faster end, which may reflect a focused substantial-equivalence argument against a well-characterized predicate.
- Applicant
- Modular Medical
- Product code
- LZG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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, 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.