K253534
- 510(k) number
- K253534
- Device name
- Pivot Insulin Delivery System
- Applicant
- Modular Medical CA · US
- Product code
- LZG — Pump, Infusion, Insulin
- Decision date
- 2026-04-08
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253534.pdf
Official FDA record: K253534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.