{"id":"855bec7b-41b2-4f5b-885e-e02096d8e8ba","slug":"fda-k234070-dexcom-stelo","filingNumber":"K234070","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"fd5648f6-a93c-460e-918c-021449c44e97","filingDate":"2023-12-22T12:00:00.000Z","decisionDate":"2024-03-05T12:00:00.000Z","status":"cleared","clearanceScope":"510(k) clearance for the Dexcom Stelo Glucose Biosensor System, the first OTC continuous glucose monitor; cleared March 2024.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070","title":"FDA 510(k) K234070 - Dexcom Stelo OTC CGM","sourceName":"FDA 510(k) Database (primary)"}],"verificationPosture":"verified","capFlagNotes":"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.","relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:09:22.137Z","updatedAt":"2026-06-05T15:35:47.731Z","applicantCompany":{"id":"fd5648f6-a93c-460e-918c-021449c44e97","slug":"dexcom","name":"Dexcom"},"modelLinks":[{"id":"e2faeea6-5da3-4631-bf80-4864c3a2f3b3","modelId":"d3f4598c-3c0a-4a99-a235-d0d94eebf947","regulatoryFilingId":"855bec7b-41b2-4f5b-885e-e02096d8e8ba","createdAt":"2026-06-04T23:09:22.295Z","model":{"slug":"stelo","modelName":"Stelo"}}]}