{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-22-011557","form_type":"8-K","ticker":"OM","cik":"0001484612","company_name":"Outset Medical, Inc.","filed_at":"2022-06-13T23:59:59+00:00","discovered_at":"2026-05-14T18:04:00.874042+00:00","generated_at":"2026-06-25T02:19:25.791244+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Outset Medical halts home Tablo shipments pending FDA 510(k) review; guides Q2 rev at least $25M","bullets":["Shipment hold on new Tablo Hemodialysis Systems for home use pending FDA 510(k) clearance of post-March 2020 changes.","Q2 2022 revenue expected at least $25M; prior FY2022 guidance suspended until early August update.","No safety issues identified; Tablo continues to sell for chronic and acute care settings.","Already-distributed home devices not removed; current users can continue treatment with providers.","Company expects update on regulatory review process in Q3 2022."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-22-011557","json":"https://secwatch.observer/filing/0000950170-22-011557.json","markdown":"https://secwatch.observer/filing/0000950170-22-011557.md","text":"https://secwatch.observer/filing/0000950170-22-011557.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1484612/000095017022011557/0000950170-22-011557-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1484612/000095017022011557/om-20220613.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T02:19:25.791244+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"}