Regulatory filing
K234070 (us_fda)
510(k) clearance for the Dexcom Stelo Glucose Biosensor System, the first OTC continuous glucose monitor; cleared March 2024.
fda 510k · cleared · decided 2024-03-05
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-k234070-dexcom-stelo.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/855bec7b-41b2-4f5b-885e-e02096d8e8ba
- Revision history: /regulatory-filings/fda-k234070-dexcom-stelo/history
- Data documentation: /data
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
Covered models (1)
Sources (1)
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Identity
855bec7b-41b2-4f5b-885e-e02096d8e8ba