{"id":"f5cc282c-68ae-4302-ae99-a7348106157b","slug":"fda-k212372-fitbit-afib","filingNumber":"K212372","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"0334d79c-2278-4c3f-a513-f133eb9a1db6","filingDate":"2021-07-30T12:00:00.000Z","decisionDate":"2022-04-08T12:00:00.000Z","status":"cleared","clearanceScope":"510(k) clearance for the Fitbit irregular heart rhythm notification (PPG-based AFib detection); cleared 2022.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212372","title":"FDA 510(k) K212372 - Fitbit irregular rhythm notifications","sourceName":"FDA 510(k) Database (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:08:20.970Z","updatedAt":"2026-06-05T15:35:46.727Z","applicantCompany":{"id":"0334d79c-2278-4c3f-a513-f133eb9a1db6","slug":"fitbit","name":"Fitbit"},"modelLinks":[{"id":"b89d1e64-4a5d-4539-8e4d-4cffe793a7cc","modelId":"fab68c69-1024-4aa2-8528-243454922840","regulatoryFilingId":"f5cc282c-68ae-4302-ae99-a7348106157b","createdAt":"2026-06-04T23:08:21.125Z","model":{"slug":"fitbit-tracker","modelName":"Fitbit (Charge / Sense / Versa)"}}]}