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NEPHROS, INC.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
H2H Water Filter	70-7828	FDA UDI	Class II	Unknown
EndoPur Endotoxin 10" Filter Fin	70-0110F	FDA UDI	Class II	Unknown
OLpur MD 220 - FDA	70-1220	FDA UDI	Class II	Active
Nephros SSUmini UltraFilter	70-0242	FDA UDI	Class II	Active
Nephros Dsu-H, Nephros Ssu-H	K141731	FDA 510(k)	Class II	Active
Nephros, Inc., Dsu Dual Stage Ultrafilter	K090885	FDA 510(k)	Class II	Active
HDF Assist Mudule, HDF Infusion Set and Substitution Filter	K210575	FDA 510(k)	Class II	Active
Nephros S100	K153084	FDA 510(k)	Class II	Active
Nephros Olpur H2h Hemodiafiltration (hdf) Module And Olpur Md 220 Hemodiafilter	K112314	FDA 510(k)	Class II	Active
Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter	K110285	FDA 510(k)	Class II	Active
HydraGuard 10 UltraFilter	K161467	FDA 510(k)	Class II	Active
EndoPur Filter	K161304	FDA 510(k)	Class II	Active
Olpur Dialyzer, Model Hd 190	K050603	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 28, 2013	Z-0488-2014	—	terminated	Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Oct 28, 2013	Z-0490-2014	—	terminated	Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Oct 28, 2013	Z-0487-2014	—	terminated	Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.