---
schema_version: "secwatch.filing_event.v1"
accession: "0001438133-24-000047"
form_type: "8-K"
ticker: "TNDM"
cik: "0001438133"
company_name: "TANDEM DIABETES CARE INC"
filed_at: "2024-04-01T23:59:59+00:00"
generated_at: "2026-06-04T04:26:54.606242+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA clears Tandem Mobi insulin pump for pediatric use ages 2+

## Summary
- FDA cleared Tandem Mobi insulin pump for expanded pediatric indication in individuals two years and older.
- Clearance was granted via 510(k) application on March 21, 2024.
- Indication expansion broadens Tandem's addressable patient population beyond prior adult-only use.

## SEC filing metadata
- accession: 0001438133-24-000047
- form_type: 8-K
- ticker: TNDM
- cik: 0001438133
- company_name: TANDEM DIABETES CARE INC
- filed_at: 2024-04-01T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438133/000143813324000047/0001438133-24-000047-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438133/000143813324000047/tndm-20240321.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438133-24-000047
- JSON: https://secwatch.observer/filing/0001438133-24-000047.json
- Plain text: https://secwatch.observer/filing/0001438133-24-000047.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.