secwatch.observer — SEC 8-K summary
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Issuer:     NEPHROS INC (NEPH)
CIK:        0001196298
Form:       8-K
Filed at:   2022-05-17T23:59:59+00:00
Accession:  0001493152-22-014190
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Nephros receives FDA 510(k) clearance for second-generation HDF Assist Module for hemodiafiltration therapy
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1196298/000149315222014190/0001493152-22-014190-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1196298/000149315222014190/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-22-014190

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