---
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"
generated_at: "2026-06-25T11:19:13.491311+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-22-014190
- JSON: https://secwatch.observer/filing/0001493152-22-014190.json
- Plain text: https://secwatch.observer/filing/0001493152-22-014190.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.