510(k) K253534 ยท LZG Pump, Infusion, Insulin
Pivot Insulin Delivery System
| Applicant | Modular Medical, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 8, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253534
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.