---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-036843"
form_type: "8-K"
ticker: "TNDM"
cik: "0001438133"
company_name: "TANDEM DIABETES CARE INC"
filed_at: "2023-11-06T23:59:59+00:00"
generated_at: "2026-06-08T19:35:41.563461+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Tandem Diabetes receives FDA clearance for t:slim X2 pump and Control-IQ for children 2+

## Summary
- FDA cleared 510(k) applications for t:slim X2 insulin pump and Control-IQ technology enhancements on Nov 3, 2023.
- Expanded pediatric indication now includes individuals two years of age and older.
- This clearance broadens the eligible patient population for Tandem's automated insulin delivery system.

## SEC filing metadata
- accession: 0001628280-23-036843
- form_type: 8-K
- ticker: TNDM
- cik: 0001438133
- company_name: TANDEM DIABETES CARE INC
- filed_at: 2023-11-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438133/000162828023036843/0001628280-23-036843-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438133/000162828023036843/tndm-20231103.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-036843
- JSON: https://secwatch.observer/filing/0001628280-23-036843.json
- Plain text: https://secwatch.observer/filing/0001628280-23-036843.txt

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