# Nephros, Inc.

- Location (FDA's records): River Edge, NJ
- FDA decisions: 9 (2005–2022): 9 510(k) clearances
- Names in FDA's records: Nephros, Inc. (8); Nephros (1)
- Product codes: KDI (3), FIP (3), NHV (3)
- 510(k) review time since 2016: median 209 days, against 203 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 16 (4 its own); citations of its devices by later devices: 9 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Minntech Corp.: 4 (https://510kreport.com/company/minntech)
- Gambro Healthcare: 1 (https://510kreport.com/company/gambro-healthcare)
- Asahi Medical Co., Ltd.: 1 (https://510kreport.com/company/asahi-medical)
- Aksys, Ltd.: 1 (https://510kreport.com/company/aksys)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)
- Fresenius Medical Care North America: 1 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Codan US Corp.: 1 (https://510kreport.com/company/codan-us)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)

## Firms that cite its devices most
- Fresenius Medical Care: 1 (https://510kreport.com/company/fresenius-medical-care)
- Pall International Sarl: 1 (https://510kreport.com/company/pall-international)
- Aqua-Tools: 1 (https://510kreport.com/company/aqua-tools)
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)
- Evoqua Water Technologies, LLC: 1 (https://510kreport.com/company/evoqua-water-technologies)

## Its most-cited devices
- K141731: Nephros Dsu-H, Nephros Ssu-H (2014), cited by 3
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), cited by 2
- K050603: Olpur Dialyzer, Model HD 190 (2005), cited by 1
- K090885: Nephros, Inc., Dsu Dual Stage Ultrafilter (2009), cited by 1
- K153084: Nephros S100 (2016), cited by 1
- K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter (2022), cited by 1

## Recent decisions
- K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter (May 13, 2022)
- K161304: EndoPur Filter (Mar 2, 2017)
- K161467: HydraGuard 10 UltraFilter (Dec 22, 2016)
- K153084: Nephros S100 (Apr 8, 2016)
- K141731: Nephros Dsu-H, Nephros Ssu-H (Oct 24, 2014)
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (Apr 27, 2012)
- K110285: Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter (Jul 14, 2011)
- K090885: Nephros, Inc., Dsu Dual Stage Ultrafilter (Jun 29, 2009)

Source page: https://510kreport.com/company/nephros