Pivot Insulin Delivery System
FDA 510(k) clearance K253534 · decided 2026-04-08
Clearance details
- K-number
- K253534
- Device name
- Pivot Insulin Delivery System
- Applicant
- Modular Medical
- Decision
- Substantially Equivalent
- Date received
- 2025-11-13
- Decision date
- 2026-04-08
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.