# K234070 (us_fda)

510(k) clearance for the Dexcom Stelo Glucose Biosensor System, the first OTC continuous glucose monitor; cleared March 2024.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K234070
- Filing date: 2023-12-22
- Decision date: 2024-03-05
- Verification posture: verified
- Cap-flag notes: Some secondary coverage described Stelo's pathway as a De Novo for the novel OTC-CGM category; the FDA 510(k) database lists K234070. Recorded per primary record; flagged.

## Applicant

- [Dexcom](/companies/dexcom.md)

## Covered models (1)

- [Stelo](/models/stelo.md)

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070)

_Canonical URL: /regulatory-filings/fda-k234070-dexcom-stelo. HTML version: [/regulatory-filings/fda-k234070-dexcom-stelo](/regulatory-filings/fda-k234070-dexcom-stelo)._