{"schema_version":"secwatch.filing_event.v1","accession":"0001438133-25-000072","form_type":"8-K","ticker":"TNDM","cik":"0001438133","company_name":"TANDEM DIABETES CARE INC","filed_at":"2025-05-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.300639+00:00","generated_at":"2026-05-21T23:22:08.497407+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Tandem Diabetes receives FDA 510(k) clearance for SteadiSet infusion set (3-day use); plans 7-day submission","bullets":["FDA cleared SteadiSet infusion set for up to 3 days of use; submission by subsidiary CapBio.","SteadiSet features integrated inserter with hidden needle for one-handed insertion; for adults with Type 1 diabetes.","Tandem intends to submit separate 510(k) to extend use to up to 7 days; commercial activities delayed until clearance.","No immediate revenue impact; commercial launch deferred pending 7-day clearance."],"urls":{"canonical":"https://secwatch.observer/filing/0001438133-25-000072","json":"https://secwatch.observer/filing/0001438133-25-000072.json","markdown":"https://secwatch.observer/filing/0001438133-25-000072.md","text":"https://secwatch.observer/filing/0001438133-25-000072.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438133/000143813325000072/0001438133-25-000072-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438133/000143813325000072/tndm-20250509.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T23:22:08.497407+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}