{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-22-032483","form_type":"8-K","ticker":"OWLT","cik":"0001816708","company_name":"Owlet, Inc.","filed_at":"2022-12-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:52.281989+00:00","generated_at":"2026-06-21T00:11:09.615822+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA accepts Owlet's de novo submission for Health Notifications SaMD for heart rate and oxygen","bullets":["FDA accepted for substantive review Owlet's de novo classification request for over-the-counter SaMD 'Health Notifications'.","Health Notifications would provide live heart rate and oxygen saturation displays and notifications via Dream Sock.","This is Owlet's second FDA submission in 2022; first was a 510(k) for a prescription monitor in October.","CEO Kurt Workman stated FDA authorization could uniquely position Owlet to help caregivers with live health data.","De novo pathway is for low-to-moderate risk devices with no legally marketed predicate."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-22-032483","json":"https://secwatch.observer/filing/0001628280-22-032483.json","markdown":"https://secwatch.observer/filing/0001628280-22-032483.md","text":"https://secwatch.observer/filing/0001628280-22-032483.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1816708/000162828022032483/0001628280-22-032483-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1816708/000162828022032483/owlt-20221222.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T00:11:09.615822+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"}