{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-22-014190","form_type":"8-K","ticker":"NEPH","cik":"0001196298","company_name":"NEPHROS INC","filed_at":"2022-05-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:59.961530+00:00","generated_at":"2026-06-25T11:19:13.491311+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Nephros receives FDA 510(k) clearance for second-generation HDF Assist Module for hemodiafiltration therapy","bullets":["First and only FDA-cleared device in the US to provide hemodiafiltration therapy to ESRD patients.","Enables existing hemodialysis machines to perform HDF without costly new equipment.","Majority-owned subsidiary Specialty Renal Products to pilot device in select clinics.","No financial impact or revenue guidance change disclosed in the filing."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-22-014190","json":"https://secwatch.observer/filing/0001493152-22-014190.json","markdown":"https://secwatch.observer/filing/0001493152-22-014190.md","text":"https://secwatch.observer/filing/0001493152-22-014190.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1196298/000149315222014190/0001493152-22-014190-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1196298/000149315222014190/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T11:19:13.491311+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"}